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U.S. Department of Health and Human Services

Medical Devices

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May 2011 PMA Approvals

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P090028
5/11/11
VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and ControlsOrtho-Clinical Diagnostics, Inc. Rochester, NY
14626
Approval for the VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls. This device is indicated for: VITROS® Immunodiagnostic Products HBeAg Reagent Pack – For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the VITROS® ECi/ECiQ Immunodiagnostic System. Test results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection. VITROS® Immunodiagnostic Products HBeAG Calibrator – For use in the calibration of the VITROS® ECi/ECiQ Immunodiagnostic Systems for the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection. VITROS® Immunodiagnostic Products HBeAg Controls - For use in monitoring the performance of the VITROS® ECi/ECiQ Immunodiagnostic Systems when used for the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection when using the VITROS® Immunodiagnostic Products HBe-Ag Reagent Pack.
P100013
5/19/11
EXOSEAL Vascular Closure DeviceCordis Corporation
Bridgewater, NJ
08807
Approval for the EXOSEAL Vascular Closure Device. This device is indicated as follows: The EXOSEAL Vascular Closure Device (VCD) is indicated for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization procedures using a standard 5F, 6F, or 7F vascular sheath introducer with up to 12 cm working length. Additionally, the EXOSEAL VCD is indicated to reduce times to hemostasis and ambulation in patients who have undergone interventional catheterization procedures, using a standard 6F vascular sheath introducer up to a 12 cm working length, who have received preprocedural and/or intraprocedural glycoprotein (GP) IIb/IIIa inhibitor therapy.
P100014
5/27/11
Solesta®Oceana Therapeutics, Inc.
Edison, NJ
08817
Approval for the Solesta®. This device is indicated for the treatment of fecal incontinence in patients 18 years and older who have
failed conservative therapy (e.g., diet, fiber therapy, anti-motility medications).
P100017
5/17/11
Abbott RealTime HCV, Abbott RealTime HCV Amplification Reagent Kit, Abbott RealTime HCV Control Kit, Abbott RealTime HCV Calibrator Kit, and optional UNG Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCVAbbott Molecular, Inc.
Des Plaines, IL
60018
 
Approval of Abbott RealTime HCV, Abbott RealTime HCV Amplification Reagent Kit, Abbott RealTime HCV Control Kit, Abbott RealTime HCV Calibrator Kit, and optional UNG Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV. This device is indicated for: Abbott RealTime HCV Amplification Reagent Kit – The Abbott Real Time HCV assay is an in vitro reverse transcription- polymerase chain reaction (RT-PCR) assay for use with the Abbott mSample Preparation System reagents and with the Abbott m2000sp and m2000ry4 instruments for the quantitation of hepatitis C viral (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. Specimens containing HCV genotypes 1-6 have been validated for quantitation in the assay. The Abbott RealTime HCV assay is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non- sustained virological response to HCV therapy. The results from the RealTime HCV assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a or 2b plus ribavirin. No information is available on the assay’s predictive value when other therapies are used. Assay performance for determining the state of HCV infection has not been established. The Abbott RealTime HCV assay is not for screening blood, plasma, serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection. Abbott RealTime HCV Control Kit – The Abbott RealTime HCV controls are used to establish run validity of the Abbott RealTime HCV assay when used for the quantitation of Hepatitis C Virus (HCV) RNA in human serum and plasma (EDTA) from HCV infected individuals. Abbott RealTime HCV Calibrator Kit – The Abbott RealTime HCV Calibrators are for calibration of the Abbott RealTime HCV assay when used for the quantitative determination of Hepatitis C Virus (HCV) RNA in human serum and plasma (EDTV) for HCV infected individuals. Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV – This kit is to be used in conjunction with Abbott RealTime HCV, List No. In30-90, as an optional contamination control for customer laboratories that are currently using or have previously used amplification technologies that incorporate uracil into the amplification product.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
D970003/S128
5/17/11
Real-Time
Latitude Patient Management SystemBoston Scientific CRM
St. Paul, MN
55112
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01.
P790002/S026
5/19/11
180-Day
Biomet® EBI Bone Healing SystemEBI, L.L.C.
Parsippany, NJ
07054
Approval for a modified, redesigned, noninvasive Pulsed Electromagnetic Field bone growth stimulator system that uses new SFLX coils.
P790005/S047
5/6/11
Special
OrthoGen OsteoGen Implantable Bone Growth StimulatorEBI, L.P.
Parsippany, NJ
07054
Approval for manufacturing changes involving the verification of alcohol sterility and the magnet overriding test fixture.
P820003/S104
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P820060/S026
5/20/11
180-Day
AxSYM AFPAbbott Laboratories Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois.
P840001/S182
5/6/11
135-Day
Synergy® IPG, Synergy Versitrel® IPG, RestorePrime® Implantable Neurostimulator (INS), PrimeAdvanced® INS, Restore® INS, RestoreUltra® INS and RestoreAdvanced® INS Model FamiliesMedtronic, Inc.
Minneapolis, MN
55432
Approval for the addition of an optional deburring process.
P840064/S044
5/27/11
135-Day
DISCOVISC®, DUOVISC® and VISCOAT® Ophthalmic Viscosurgical DevicesAlcon Research, Ltd.
Fort Worth, TX
76134
Approval for the addition of a third packaging line for the DISCOVISC®, DUOVISC® and VISCOAT® Ophthalmic Viscosurgical Devices.
P840068/S048
5/17/11
Real-Time
Latitude Patient Management SystemBoston Scientific CRM
St. Paul, MN
55112
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01.
P850051/S074
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P860003/S059
5/13/11
Real-Time
THERAKOS CELLEX™ Photopheresis System – Procedural KitTHERAKOS, Inc. Raritan, NJ
08869
Approval for a minor dimensional change to a Y-adaptor in the CELLEX™ Procedural Kit and a change in the splice bond Bushing of the CELLEX™ Procedural Kit’s anticoagulant (green) line.
P860004/S149
5/6/11
135-Day
SynchroMed PumpMedtronic, Inc.
Minneapolis, MN
55432
Approval for the addition of an optional deburring process.
P880086/S183
5/11/11
180-Day
AddVent, Affinity, Identity, Verity, Integrity, Victory, Zephyr, Accent, Trilogy, Synchrony, Paragon and Phoenix Family of Pacemakers/CRT-PsSt. Jude Medical Sylmar, CA
91342
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P880086/S199
5/10/11
135-Day
Accent, Identity, Identity ADx, Verity ADx, Victory, Zephyr and Microny CRT-PsSt. Jude Medical – CRMD
Sunnyvale, CA
94086
Approval for tighter screening limits and the inclusion of a reflow thermal conditioning during the manufacture of tantalum capacitor components.
P890003/S209
5/4/11
180-Day
Application Software for Reveal ICM/Patient Assistant, Carelink Home Monitor and CardioSight MonitorMedtronic, Inc. Mounds View, MN 55112Approval for updates to Medtronic’s Reveal 2090 Application Software Model SW007 for use with the Medtronic Reveal Implantable Cardiac Monitor (ICM) System.
P890003/S211
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P890003/S220
5/27/11
Real-Time
CareLink Monitor, Revo MRI SureScan Pacing SystemMedtronic, Inc.
Mounds View, MN
55112
Approval for Model 2490G (version 9V5) Medtronic CareLink Monitor and Model 2491 Device Data Management Application (Revo MRI SW018 XMLTU and EnRhythm MRI V7.3 SW005 XMLTU).
P890047/S032
5/27/11
PROVISC® Ophthalmic Viscosurgical DeviceAlcon Research, Ltd.
Fort Worth, TX
76134
Approval for the addition of a third packaging line for the DISCOVISC®, DUOVISC® and VISCOAT® Ophthalmic Viscosurgical Devices.
P890055/S032
5/10/11
Real-Time
MedStream Programmable Infusion SystemCodman & Shurtleff, Incorporated Raynam, MA
02767
Approval for a new adhesive to secure the antenna and modification to the piezo actuator release specification. The device, as modified, will be marketed under the trade name MedStream Programmable Infusion System and is indicated for the chronic intrathecal infusion of baclofen injection sterile solution (5.0 pH to 7.0 pH) in the treatment of severe spasticity.
 
P890055/S033
5/23/11
Real-Time
MedStream Programmable Infusion SystemCodman & Shurtleff, Incorporated
Raynham, MA
02767
Approval for software modification to the MedStream Programmable Infusion System. The modified MedStream Pump will have software PS-100044 version 3.06, the modified Control Unit will have software PS-100046 version 3.00. PS-100045 version 3.04, PS-1000047 version 3.09 and PS-100021 version 2.00. The device,
as modified, will be marketed under the trade name MedStream Programmable Infusion System and is indicated for the chronic intrathecal infusion of baclofen injection sterile
solution (5.0 pH to 7.0pI I) in the treatment of severe spasticity.
P900061/S098
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P910007/S022
5/20/11
180-Day
AxSYM Total PSAAbbott Laboratories Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois.
P910023/S227
5/11/11
180-Day
Cadence, Cadet, Contour, Contour II/MD, Atlas II/MD, Profile II/MD, Photon, Photon Micro, Current, Current+, Atlas II, Atlas+, Epic II, Epic+, and Convert Families of ICDs/ CRT-DsSt. Jude Medical Sylmar, CA
91342
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P910023/S258
5/10/11
135-Day
Atlas II, Atlas+, Epic+, Epic II, Epic II+, Current RF Current +, Current Accel and Fortify ICDsSt. Jude Medical – CRMD
Sunnyvale, CA
94086
Approval for tighter screening limits and the inclusion of a reflow thermal conditioning during the manufacture of tantalum capacitor components.
P910077/S111
5/17/11
Real-Time
Latitude Patient Management SystemBoston Scientific CRM
St. Paul, MN
55112
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01.
P920015/S056
5/13/11
180-Day
Subcutaneous Lead System and Transvene SVC LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Center Villalba in Villalba, Puerto Rico.
P930014/S045
5/3/11
Panel-Track
ACRYSOF® Toric Posterior Chamber Intraocular Lens and AcrySOF® IQ Toric Posterior Chamber Intraocular LensAlcon Research Ltd. Fort Worth, TX 76134Approval for the ACRYSOF® Toric Posterior Chamber Intraocular Lens Models SN60T6, SN60T7, SN60T8, and SN60T9 and AcrySOF® IQ Toric Posterior Chamber Intraocular Lens Models SN6AT6, SN6AT7, SN6AT8 and SN6AT9. This device is indicated for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.
P930022/S012
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P940031/S070
5/17/11
Real-Time
Latitude Patient Management SystemBoston Scientific CRM
St. Paul, MN
55112
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01.
P950022/S067
5/11/11
180-Day
Riata, Riata ST, Riata ST Optim and Durata Family of LeadsSt. Jude Medical Sylmar, CA
91342
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P950037/S096
5/26/11
Real-Time
Implantable Pulse GeneratorsBiotronik, Inc.
Lake Oswego, OR 97035
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs.
P960006/S029
5/19/11
135-Day
Transvenous Bipolar Pacing LeadBoston Scientific – CRM
St. Paul, MN
55112
Approval for a change to laser welding equipment used in the manufacture of pacing leads.
P960009/S112
5/6/11
135-Day
Kinetra® INS, Activa® PC INS, Activa® SC INS, Activa® RC INS Model FamiliesMedtronic, Inc.
Minneapolis, MN
55432
Approval for the addition of an optional deburring process.
P960013/S055
5/11/11
180-Day
Tendril, Tendril ST, Tendril STS and OptiSense Family of LeadsSt. Jude Medical Sylmar, CA
91342
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P960030/S028
5/11/11
180-Day
Passive Plus, IsoFlex S, IsoFlex P and IsoFlex Optim Family of LeadsSt. Jude Medical Sylmar, CA
91342
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P960040/S242
5/17/11
Real-Time
Latitude Patient Management SystemBoston Scientific CRM
St. Paul, MN
55112
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01.
P970004/S109
5/6/11
135-Day
InterStim® II INSMedtronic, Inc.
Minneapolis, MN
55432
Approval for the addition of an optional deburring process.
P970012/S081
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P970027/S011
5/20/11
180-Day
AxSYM Anti-HCVAbbott Laboratories
Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois.
P980007/S014
5/20/11
180-Day
AxSYM Free PSAAbbott Laboratories Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois.
P980016/S273
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P980016/S295
5/26/11
Real-Time
Protecta, Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families.
P980023/S044
5/26/11
Real-Time
Drug-eluting Permanent Pacemaker/ Defibrillator ElectrodesBiotronik, Inc.
Lake Oswego, OR 97035
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs.
P980035/S200
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P980035/S209
5/19/11
135-Day
Adapta/Relia/Sensia/ Versa Families of Implantable Pulse GeneratorsMedtronic, Inc.
Mounds View, MN
55112
Approval for update of the EEPROM serial number.
P980035/S219
5/26/11
Real-Time
AdvisaMedtronic, Inc.
Mounds View, MN
55112
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families.
P980050/S043
5/13/11
180-Day
Transvene CS/SVC LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Center Villalba in Villalba, Puerto Rico.
P980050/S057
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P990001/S082
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P990004/S017
5/31/11
Real-Time
Surgifoam® Hemostatic Matrix KitEthicon, Inc.
Somerville, NJ
08876
Approval for changes to the reconstitution of method for the thrombin component and modified the method of mixing with the powdered gelatin component.
P990004/S019
5/17/11
180-Day
SURGIFLO® Hemostatic Matrix and SURGIFLO® Hemostatic Matrix Kit with ThrombinEthicon, Inc.
Somerville, NJ
08876
Approval for the introduction of a new Hemostatic Matrix formulation, redesign of the application components, reorganization of the packaging, and addition of EVITHROM lyophilized thrombin labeling directly into the directions for use as well as other updated labeling changes.
P000009/S045
5/26/11
Real-Time
Single and Dual Chamber ICDBiotronik, Inc.
Lake Oswego, OR 97035
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs.
P000012/S026
5/24/11
135-Day
COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, version 2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for eliminating aurintricarboxylic acid (ATA) activity testing in COBAS AmpliPrep/ COBAS AMPLICOR HCV Internal Control Buffer and Specimen Diluent bulk solutions.
P010012/S265
5/17/11
Real-Time
Latitude Patient Management SystemBoston Scientific CRM
St. Paul, MN
55112
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01.
P010014/S029
5/3/11
135-Day
Oxford® Partial Knee Twin Peg Femoral ComponentsBiomet, Inc.
Warsaw, IN
46581
Approval for additional manufacturing steps for the Oxford® Partial Knee Twin Peg Femoral components.
P010015/S107
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P010015/S119
5/26/11
Real-Time
Consulta CRT-P, Syncra CRT-P ModuleMedtronic, Inc.
Mounds View, MN
55112
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families.
P010019/S022
5/18/11
135-Day
CIBA VISION (lotrafilcon B) Soft Contact LensesCIBA VISION Corporation
Duluth, GA
30097
Approval to change the plasma coating parameters.
P010031/S228
5/13/11
180-Day
Medtronic CareLink ProgrammerMedtronic, Inc.
Mounds View, MN
55112
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer.
P010031/S249
5/26/11
Real-Time
Protecta, Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families.
P010033/S017
5/26/11
Special
QuantiFERON® TB-Gold In-TubeCellestis, Incorporated
Valencia, CA
91355
Approval for revisions to the device package insert and marketing booklet subsequent to the publication of the CDC's Updated Guidelinesfor Using Interferon Gamma
Release Assays to Detect Mycobacterium tuberculosis Infection - United States, 2010, in
accordance with the original PMA post-approval requirement.
P010050/S012
5/12/11
Real-Time
IMMULITE 2000® XPi HBsAgSiemens Healthcare Diagnostics
Tarrytown, NY
10591
Approval for introduction of a new instrument model, the IMMULITE 2000® XPi Analyzer, as a new family member of the currently approved IMMULITE 2000® Analyzer, to be used with the currently approved IMMULITE 2000® HBsAG assay. The device, as modified, will be marketed under the trade name IMMULITE 2000® HBsAG assay an is indicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information.
P010051/S008
5/12/11
Real-Time
IMMULITE 2000® XPi Anti HBcSiemens Healthcare Diagnostics
Tarrytown, NY 10591
Approval for introduction of a new instrument model, the IMMULITE 2000® XPi Analyzer, as a new family member of the currently approved IMMULITE 2000® Analyzer, to be used with the currently approved IMMULITE 2000® Anti-HBc assay. The device, as modified, will be marketed under the trade name IMMULITE 2000® XPi Anti-HBce assay an is indicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information.
P010052/S008
5/12/11
Real-Time
IMMULITE 2000® Anti-HBsSiemens Healthcare Diagnostics
Tarrytown, NY
10591
Approval for introduction of a new instrument model, the IMMULITE 2000® XPi Analyzer, as a new family member of the currently approved IMMULITE 2000® Analyzer, to be used with the currently approved IMMULITE2000® Anti-HBs assay. The device, as modified, will be marketed under the trade IMMULITE 2000® XPi Anti-HBs assay and is indicated for in vitro diagnostic use for the detection of anti-HBs and is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection.
P010053/S007
5/12/11
Real-Time
IMMULITE 2000® XPi Anti-HBc IgMSiemens Healthcare Diagnostics
Tarrytown, NY
10591
Approval for introduction of a new instrument model, the IMMULITE 2000® XPi Analyzer, as a new family member of the currently approved IMMULITE 2000® Analyzer, to be used with the currently approved IMMULITE 2000® Anti-HBc IgM assay. The device, as modified, will be marketed under the trade name IMMULITE 2000® XPi Anti-HBc IgM assay and is indicated for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis b virus infections in conjunction with other serological and clinical information.
P020026/S059
5/27/11
180-Day
CYPHER® Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTRORAIL® Rapid Exchange Delivery SystemCordis Corporation Miami Lakes, FL 33014Approval for the XTEND manufacturing process and an extension of your approved shelf life from 3 to 6 months.
P020026/S083
5/27/11
Real-Time
CYPHER® Sirolimus-Eluting Coronary Stent SystemCordis Corporation Miami Lakes, FL
33014
Approval for updated Magnetic Resonance Imaging (MRI) compatibility testing and MRI conditions of use labeling.
P020047/S032
5/19/11
135-Day
Multi-Link Vision, Multi-Link Mini-Vision OTW and RX, Multi-Link 8™, Multi-Link 8 LL™, Multi-Link 8 SV™ Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA 92590
Approval to remove a redundant verification step for a spiral mandrel used in the stent manufacturing process.
P030005/S073
5/17/11
Real-Time
Latitude Patient Management SystemBoston Scientific CRM
St. Paul, MN
55112
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01.
P030006/S024
5/13/11
180-Day
Prolieve Thermodilation SystemBoston Scientific Corporation
Marlborough, MA 01752
Approval of the post-approval study protocol.
P030016/S019
5/5/11
180-Day
Visian ICLStar Surgical
Monrovia, CA
91016
Approval of the post-approval study protocol.
P030017/S118
5/9/11
Real-time
Precision® Spinal Cord Stimulation (SCS) SystemBoston Scientific Neuromodulation Corporation
Valencia, CA
91355
Approval for a change in the outer box used as secondary packaging for lead and extensions.
P030035/S064
5/11/11
180-Day
Frontier, Frontier II, Aescula and Anthem Family of Pacemakers/ CRT-PsSt. Jude Medical Sylmar, CA
91342
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC located in Arecibo, Puerto Rico.
P030035/S079
5/10/11
135-Day
Anthem and Frontier II PacemakersSt. Jude Medical – CRMD
Sunnyvale, CA
94086
Approval for tighter screening limits and the inclusion of a reflow thermal conditioning during the manufacture of tantalum capacitor components.
P030036/S022
5/5/11
180-Day
AS Anchoring Sleeve KitMedtronic, Inc.
Mounds View, MN
55112
Approval for manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) in Villabla, Puerto Rico.
P030052/S006
5/26/11
Special
UroVysion Bladder Cancer KitAbbott Molecular, Inc.
Des Plaines, IL
60018
Approval for a labeling change to the UroVysion Bladder Cancer Kit package insert to correct an inaccuracy in a labeling schematic in the UroVysion Package Insert 30-608358 identified during a review of the package insert.
P030054/S142
5/11/11
180-Day
Epic HF, Epic+ HF, Epic II HF, Epic II+ HF, Atlas HF, Atlas+ HF, Atlas II HF, Atlas+ HF, Atlas+ II HF Family of ICDs/CRT-Ds, Promote, Promote+ Families of ICDs/CRT-Ds, QuickSite, QuickFlexSt. Jude Medical Sylmar, CA
91342
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P030054/S182
5/11/11
Real-Time
CRT LeadsSt. Jude Medical
Sylmar, CA
91342
Approval for a dimensional change to the IS-1 connector front seal.
P030054/S183
5/10/11
135-Day
Atlas +HF, Epic HF, Epic +HF, Promote RF, Promote +, Promote Accel and Unify CRT-DsSt. Jude Medical – CRMD
Sunnyvale, CA
94086
Approval for tighter screening limits and the inclusion of a reflow thermal conditioning during the manufacture of tantalum capacitor components.
P040001/S019
5/4/11
Real-Time
X-STOP Interspinous Spacer SystemMedtronic Spine, LLC
Sunnyvale, CA
94089
Approval for implementation of new instrument cleaning and sterilization processes and is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis (with X-Ray, MRI, and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing). The X-STOP® Spacer is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/ buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X-STOP Spacer may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
P040002/S031
5/6/11
180-Day
AFX Endovascular AAA SystemEndologix, Inc.
Irvine, CA
92618
Approval for a new ePTFE graft process as well as changes to the delivery system.
P040012/S034
5/6/11
Panel-Track
RX Acculink Carotid Stent SystemAbbott Vascular Santa Clara, CA
95054
Approval for the RX Acculink Carotid Stent System. The device is indicated for high surgical risk and standard surgical risk patients as follows: High Surgical Risk – Th RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular’s Accunet or Emboshield family of Embolic Protection Systems (EPS), is indicated for the treatment of revascularization and meet the criteria outlined below:
1) patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; and patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. Standard Surgical Risk – Th RX Acculink Carotid Stent System, used in conjunction with the Accunet Embolic Protection System (EPS), is indicated for the treatment of patients at standard risk for adverse events from cartoid endarterectomy who require carotid revascularization and meet the criteria outlined below:
1) patients with neurological symptoms and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram OR patients without neurological symptoms and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram; and patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
P040013/S016
5/27/11
180-Day
GEM 21S®Luitpold Pharmaceuticals, Incorporated
Norristown, PA
19403
Approval for a change in the rh-PDGF-BB syringe cap material, made by Becton Dickinson, the cap supplier, from West 1883 to Helovet FM27, based on a change in Becton Dickinson rubber raw materials suppliers.
P050012/S033
5/19/11
135-Day
Dexcom™ SEVEN® and seven plus® Continuous Glucose Monitoring SystemDexcom, Inc.
San Diego, CA
92121
Approval for a proposed change to eliminate redundant post-winding and post-second-parylene visual inspection for the sensor component of the SEVEN® and SEVEN PLUS® Continuous Glucose Monitoring System.
P050020/S032
5/16/11
180-Day
FreeStyle Navigator® Continuous Glucose Monitoring SystemAbbott Laboratories
Alameda, CA
94502
Approval for changes to the Quality System drawings of ten Receiver and Transmitter components, used for First Article Inspection activities prior to release for manufacturing.
P050023/S045
5/26/11
Real-Time
Pulse Generator, Pacemaker Implantable with Cardiac ResynchronizationBiotronik, Inc.
Lake Oswego, OR 97035
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs.
P050047/S014
5/11/11
135-Day
Juvéderm Hyaluronate Gel ImplantsAllergan
Goleta, CA
93117
Approval for the removal of an in- process quality control test used in the manufacture of Juvéderm Hyaluronate Gel Implants.
P050049/S005
5/20/11
180-Day
AxSYM HBsAg/ ConfirmatoryAbbott Laboratories
Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois.
P060003/S007
5/20/11
180-Day
AxSYM AUSABAbbott Laboratories
Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois.
P060003/S009
5/13/11
135-Day
ABBOTT AxSYM AUSABAbbott Laboratories Abbott Park, IL 60064Approval for modifications to the quality control test methods.
P060008/S070
5/24/11
180-Day
TAXUS Liberte Paclitaxel Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval of the post- approval study protocol.
P060009/S003
5/20/11
180-Day
AxSYM CORE-MAbbott Laboratories
Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois.
P060012/S005
5/20/11
180-Day
AxSYM COREAbbott Laboratories
Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois.
P060030/S018
5/5/11
Special
COBAS® AmpliPrep/COBAS TaqMan® HCV TestRoche Molecular Systems, Inc. Pleasanton, CA 94588Approval for an addition to the COBAS® AmpliPrep/COBAS TaqMan® HCV Test v1.0 Package Insert.
P060035/S005
5/20/11
135-Day
ARCHITECT CORE-MAbbott Laboratories
Abbott Park, IL
60064
Approval for changes to manufacturing methods and process changes.
P070005/S002
5/5/11
180-Day
REPEL-CV Bioresorbable Adhesion BarrierSynthemed Corporation
Iselin, NJ
08830
Approval of the post-approval study protocol.
P070008/S023
5/26/11
Real-Time
Defibrillator, Automatic Implantable Cardioverter with Cardiac ResynchronizationBiotronik, Inc.
Lake Oswego, OR 97035
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs.
P070015/S036
5/23/11
180-Day
XIENCE V® Everolimus Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Approval for updates to your labeling to include 1-year results from the SPIRIT IV trial, a pooled SPIRIT II-III-IV analysis, gender-specific analyses, and updated results from the SPIRIT FIRST, II, and III trials.
P070015/S054
5/24/11
Panel-Track
XIENCE nano™ Everolimus Eluting Coronary Stent System and PROMUS™ Everolimus Eluting Coronary Stent SystemAbbott Vascular
Santa Clara, CA
95054
Approval to expand the product matrix to include the 2.25 mm XIENCE™ V Everolimus Eluting Coronary Stem System. This device size will be marketed under the trade
name XIENCE nano™ Everolimus Eluting Coronary Stem System and will also be distributed as
the PROMUS ™ Everolimus Eluting Coronary Stent System. The addition of the 2.25 mm XIENCE nano™ Everolimus Eluting Coronary Stent System will
expand the originally approved indications to include treatment of coronary artery lesions with
reference vessel diameters >2.25 mm to <2.50 mm. Therefore, the XIENCE™ V Everolimus
Eluting Coronary Stent System is now indicated for improving coronary luminal diameter in
patients with symptomatic heart disease due to de novo native coronary artery lesions (length
< 28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm.
P070015/S060
5/19/11
135-Day
XIENCE V® and Promus® Everolimus Eluting Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA 92590
Approval to remove a redundant verification step for a spiral mandrel used in the stent manufacturing process.
P070022/S008
5/5/11
135-Day
Adiana Permanent Contraception SystemHologic, Inc.
Marlborough, MA
01752
Approval for revision of written work instructions for a soldering operation.
P070022/S019
5/27/11
180-Day
Adiana Permanent Contraception
System
Hologic, Inc.
Marlborough, MA
01752
Approval of a backup sterilization facility located at Biotest Laboratories, Inc., in Brooklyn Park, Minnesota.
P080013/S006
5/20/11
180-Day
DuraSeal Xact Sealant SystemCovidien
Bedford, MA
01801
Approval of the post-approval study protocol.
P080023/S005
5/20/11
135-Day
ARCHITECT COREAbbott Laboratories Abbott Park, IL
60064
Approval for changes to manufacturing methods and process changes.
P080025/S001
5/6/11
135-Day
InterStim® II INSMedtronic, Inc.
Minneapolis, MN
55432
Approval for addition of an optional deburring process.
P090013/S012
5/27/11
Real-Time
Revo MRI SureScan Pacing SystemMedtronic, Inc.
Mounds View, MN
55112
Approval for Software application SW005 version 7.3 for CareLink Model 2090 Programmer.
P090013/S013
5/27/11
Real-Time
CareLink Monitor, Revo MRI SureScan Pacing SystemMedtronic, Inc.
Mounds View, MN
55112
Approval for Model 2490G (version 9V5) Medtronic CareLink Monitor and Model 2491 Device Data Management Application (Revo MRI SW018 XMLTU and EnRhythm MRI V7.3 SW005 XMLTU).
P090013/S019
5/26/11
Real-Time
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families.
P090018/S001
5/6/11
180-Day
Esteem®Envoy Medical Corporation
Saint Paul, MN 55110
Approval for the lead design (Model 7004/7504 leads) and lead manufacturing site change (Envoy Medical Corp., St. Paul, Minnesota).
P100010/S007
5/23/11
Real-Time
Arctic Front® Cardiac Cryoablation CatheterMedtronic Cryo-Cath LP
Eagan, MN
55123
Approval for changes in the leak detection circuit and blood sensor board.
P100021/S002
5/9/11
180-Day
Endurant Stent Graft SystemMedtronic, Inc.
Santa Rosa, CA
95403
Approval of the post-approval study protocol.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N18033/S055
5/20/11
VISTAKON (etafilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Use an automated Device History Record Checklist.
P780007/S045
5/13/11
Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact LensesCooper Vision Incorporated
Pleasanton, CA
94588
Utilize the dye penetration test method for testing package integrity.
P820003/S105
5/19/11
EPG Safety CableMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P820060/S029
5/12/11
Abbott AxSYM AFPAbbott Laboratories Abbott Park, IL
60064
Change the specifications for in- process testing and customer release testing for AxSYM AFP as a result of an internal review of the product relative to updated specification setting procedures.
P830061/S063
5/19/11
Capsure, Vitatron Crystaline, Vitatron Excellence+ and Vitatron Excellence PS+Medtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P840001/S183
5/4/11
RestorePrime® Implantable Neurostimulator (INS), PrimeAdvanced® INS, Restore® INS, RestoreUltra® INS, RestoreAdvanced® INS, Itrel® 3 INS, Synergy® INS and Synergy Versitrel INS Model FamiliesMedtronic, Inc.
Minneapolis, MN 55432
Implementation of newly validated process parameters for the blister sealing machine at Medtronic Puerto Rico Operations Company (MPROC) located in Juncos, Puerto Rico.
P840064/S046
5/18/11
VISCOAT Ophthalmic Viscosurgical Device, DISCOVISC Opthalmic Viscosurgical and DUOVISC Viscoelastic SystemAlcon Research, Ltd.
Fort Worth, Texas
76134
Expand the electronic batch record system to include electronic documentation of the reactor/vessel cleaning for ophthalmic viscosurgical devices.
P850089/S076
5/19/11
CapSure, CapSure Z Novus, Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse and Vitatron Impulse IIMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P860057/S078
5/5/11
Carpentier-Edwards® PERIMOUNT® BioprosthesisEdwards Lifesciences, LLC Irvine, CA
92614
Addition of a third- party supplier of the molded silicone inserts used in the devices.
P870056/S043
5/5/11
Carpentier-Edwards® Porcine BioprosthesisEdwards Lifesciences, LLC Irvine, CA
92614
Addition of a third- party supplier of the molded silicone inserts used in the devices.
P870077/S039
5/5/11
Carpentier-Edwards® Duraflex® Low Pressure BioprosthesisEdwards Lifesciences, LLC Irvine, CA
92614
Addition of a third- party supplier of the molded silicone inserts used in the devices.
P880086/S201
5/3/11
Family of CRT-PsSt. Jude Medical
Sunnyvale, CA
94086
Alternate plating supplier.
P890003/S221
5/19/11
CapSure, CapSure Model, Prodigy and Pacemaker Repair KitMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P890047/S034
5/18/11
PROVIS Ophthalmic Viscosurgical DeviceAlcon Research, Ltd.
Fort Worth, Texas
76134
Expand the electronic batch record system to include electronic documentation of the reactor/vessel cleaning for ophthalmic viscosurgical devices.
P900061/S101
5/12/11
Transvene Epicardial LeadMedtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test.
P900061/S102
5/19/11
Upsizing Sleeve, ACE, ACE 5434T, ACE Header and Lead End Pin CapMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P910007/S028
5/11/11
Abbott ARCHITECT Total PSAAbbott Laboratories
Abbott Park, IL
60064
Addition of a quality control test method and addition of an alternate manufacturing material (polypropylene resin) and an alternate vendor.
P910023/S260
5/5/11
Cadence Family of ICDsSt. Jude Medical Sylmar, CA
91342
Addition of a secondary supplier for organic substrates.
P910023/S261
5/3/11
Family of ICDsSt. Jude Medical
Sunnyvale, CA
94086
Alternate plating supplier.
P910023/S262
5/11/11
Family of ICDsSt. Jude Medical, Inc.
Sunnyvale, CA
94086
Change in the MEMS sensor mounting material.
P910054/S005
5/17/11
Toray Inoue Balloon CatheterToray Industries ( America), Inc.
New York, NY
10017
Addition of a sterilizer at your Seta plant facility.
P910073/S093
5/3/11
Reliance LeadsBoston Scientific Corporation
St. Paul, MN
55112
Replace the existing automated optical measuring system with a new system.
P920015/S075
5/12/11
Y Adaptor, Subcutaneous Lead, Transvene SVC Lead and Tunneling LeadMedtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test.
P920015/S076
5/19/11
“Y” Adaptor/ Extender Kit, DF-1 Connector Port Pin Plug, Lead Adaptor, Sprint, Sprint Quattro, Sprint Quattro Lead, Subcutaneous Lead and Transvene SVC LeadMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P930029/S029
5/19/11
Cath RF Conductor, Conductr 5 Mn 8 fr, Conductr RF MC, Contactr
Catheter, RF Conductr MC, RF Enhancr II, RF Marinr UNI, RF
Marinr MC 5/5/5, RF Marinr MC 7F 112 cm, RF Marinr MC 2-5-2,
RF Marinr MC UN 110 cm, RF Marinr MC XL 5/5/5, RF Marinr
MC XL 7 fr, RF Marinr SC 5F, RF Marinr SC XL 5fr, RF Marinr
SC XS 5fr, RF Marinr SCXL 5F, and RF Marinr SCXXL 5F
Medtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P930039/S051
5/18/11
CapSure Fix Novus and Vitatron LeadsMedtronic, Inc.
Mounds View, MN
55112
Addition of a second supplier for titanium nitride coated electrode components.
P930039/S052
5/19/11
CapSure, SureFix, Vitatron Crystalline ActFix, and Vitatron Pirouet S+Medtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P950024/S030
5/12/11
CapSure EPI Unipolar Lead and CapSure EPI Bipolar LeadMedtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test.
P950024/S031
5/19/11
CapSure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P950037/S095
5/6/11
Evia, Entovis, Estella, Effecta and Ecuro Family of PacemakersBiotronik, Inc.
Lake Oswego, OR
97035
Addition of an inspection step during the battery manufacturing process.
P960009/S114
5/4/11
Soletra® INS, Kinetra® INS, Activa® PC INS, Activa SC INS and Activa RC INS Model FamiliesMedtronic, Inc.
Minneapolis, MN 55432
Implementation of newly validated process parameters for the blister sealing machine at Medtronic Puerto Rico Operations Company (MPROC) located in Juncos, Puerto Rico.
P960030/S033
5/5/11
IsoFlex Low Voltage LeadsSt. Jude Medical – CRMD
Sylmar, CA
91342
Alternate supplier for the inner and outer coils used to manufacture low voltage leads.
P970003/S126
5/20/11
VNS Therapy® SystemCyberonics, Inc.
Houston, TX
77058
Addition of a thread gauging process to the header attachment process and the modification or final inspection process.
P970004/S110
5/4/11
InterStim® Neurostimulator and InterStim II NeurostimulatorMedtronic, Inc.
Minneapolis, MN 55432
Implementation of newly validated process parameters for the blister sealing machine at Medtronic Puerto Rico Operations Company (MPROC) located in Juncos, Puerto Rico.
P970004/S111
5/6/11
InterStim II Implantable NeurostimulatorMedtronic, Inc.
Minneapolis, MN
55432
Change in the testing equipment and test specifications.
P970012/S084
5/26/11
Kappa 400 DR IPG and Kappa 400 SR IPGMedtronic, Inc.
Mounds View, MN
55112
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging.
P970020/S063
5/12/11
Zeta RX, Ultra RX, and Ultra OTW Coronary Stent SystemsAbbott Vascular
Temecula, CA
92591
A manual to an automated process change for packaging labeling inspection.
P970021/S035
5/5/1
GYNECARE THERMACHOICE III Uterine Balloon Therapy SystemETHICON, Inc.
Somerville, NJ
08876
Change in raw material and supplier.
P980007/S019
5/11/11
Abbott ARCHITECT Free PSAAbbott Laboratories
Abbott Park, IL
60064
Addition of a quality control test method and addition of an alternate manufacturing material (polypropylene resin) and an alternate vendor.
P980016/S289
5/5/11
Protecta DR, VR, XT DR, and XT VR Model FamiliesMedtronic, Inc.
Mounds View, MN
55112
The subject devices are able to be manufactured using new plating lines at the qualified supplier.
P980016/S290
5/5/11
Protecta DR/VR and Protecta XL DR/VR Families of ICDsMedtronic, Inc.
Mounds View, MN 55112
Moving sterilization equipment within a facility and implementation of a barcode reader system.
P980016/S291
5/5/11
Protecta DR/VR and Protecta XT DR/VR Families of ICDsMedtronic, Inc.
Mounds View, MN 55112
Multiple manufacturing changes to the assembly line, equipment improvement and parameters, process monitoring, and laboratory analysis.
P980016/S292
5/5/11
Protecta DR/VR, Protecta XT DR/VRMedtronic, Inc.
Mounds View, MN 55112
Change to an epoxy dispenser parameter, the implementation of a software revision for a laser bonder, and an update to the sterile packaging operation process.
P980016/S293
5/13/11
Protecta DR/VR and Protecta XT DR/VR Families of ICDsMedtronic, Inc.
Mounds View, MN
55112
Multiple changes including a component supplier and inspection change, changes to an in-process device tester, and a change to an inspection test method.
P980016/S294
5/13/11
Protecta DR/VR and Protecta XT DR/VR Families of ICDsMedtronic, Inc.
Mounds View, MN
55112
Multiple manufacturing changes including a component test method update, implementation of a new component cleaning process, and implementation of additional labeling equipment and software.
P980016/S296
5/23/11
Protecta DR, Protecta VR, Protecta XT DR and Protecta XT VRMedtronic, Inc.
Mounds View, MN
55112
Alignment of process software versions.
P980016/S297
5/19/11
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta XT/Protecta ICD, Secura and Virtuoso IIMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P980016/S299
5/26/11
SecuraDR/VR lCD, Virtuoso II DR/VR, Maximo II DR/VR, Entrust lCD, Virtuoso lCD, Protecta DR, Protecta VR, Protecta XT DR, Protecta
- XT VR, InSync II Marquis lCD, InSync III Marquis lCD, InSync Marquis lCD, InSync Sentry ICD family, and InSync Maximo ICD
family.
Medtronic, Inc.
Mounds View, MN
55112
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging.
P980022/S097
5/20/11
Medtronic Paradigm Continuous Glucose Monitoring SystemsMedtronic, Inc.
Northridge, CA
91325
Inclusion of an alternate supplier for the case assembly used in the manufacture of the Paradigm REAL-Time and Paradigm REAL-Time Revel Insulin Pumps.
P980035/S213
5/5/11
Advisa DRMedtronic, Inc.
Mounds View, MN
55112
The subject devices are able to be manufactured using new plating lines at the qualified supplier.
P980035/S214
5/5/11
Advisa DR IPGsMedtronic, Inc.
Mounds View, MN 55112
Moving sterilization equipment within a facility and implementation of a barcode reader system.
P980035/S215
5/5/11
Advisa DRMedtronic, Inc.
Mounds View, MN 55112
Change to an epoxy dispenser parameter, the implementation of a software revision for a laser bonder, and an update to the sterile packaging operation process.
P980035/S216
5/13/11
Advisa DR IPGsMedtronic, Inc.
Mounds View, MN
55112
Multiple manufacturing changes including a component test method update, implementation of a new component cleaning process, and implementation of additional labeling equipment and software.
P980035/S217
5/18/11
EnRhythm IPG and Advisa IPGMedtronic, Inc.
Mounds View, MN
55112
Changes to the cleaning process performed on hybrid components.
P980035/S218
5/19/11
EnRhythm IPGMedtronic, Inc.
Mounds View, MN
55112
Process standardization for selected cleaning operations.
P980035/S220
5/23/11
Advisa DRMedtronic, Inc.
Mounds View, MN
55112
Alignment of process software versions.
P980035/S221
5/19/11
350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma and VersaMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P980035/S222
5/26/11
AdaptalVersa/Sensia IPG family, Relia IPG, EnRhythm IPG, Advisa DR IPG, Kappa 700,800/900 IPG family, Sigma IPG family, Medtronic 350
IPG series, EnPulse lPG, and AT500 Systems
Medtronic, Inc.
Mounds View, MN
55112
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging.
P980050/S060
5/12/11
Transvene CS/SVC LeadMedtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test.
P980050/S061
5/19/11
Transvene CS/SVC LeadMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P990001/S087
5/19/11
Vitatron DA+ C-Series and Vitatron DA+ T-SeriesMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P990001/S088
5/26/11
Dema IPG (includes Clarity DOOR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita 2, and Vita 2 DOOR), C-series lPG, and T-series
IPG
Medtronic, Inc.
Mounds View, MN
55112
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging.
P990009/S032
5/10/11
Floseal Hemostatic MatrixBaxter Healthcare Corporation
McGaw Park, IL
60085
Change in an in-process test method for the device.
P990012/S008
5/4/11
Elecsys HBsAG ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46250
Change to increase production capacity for a component common to all devices.
P990013/S031
5/4/11
STAAR Surgical Collamer Intraocular LensesSTAAR Surgical Company
Monrovia, CA
91016
Modification to the blocking process for the manufacture of the product lines.
P990023/S011
5/18/11
CELLUGEL Opthalmic Viscosurgical DeviceAlcon Research, Ltd.
Fort Worth, Texas
76134
Expand the electronic batch record system to include electronic documentation of the reactor/vessel cleaning for ophthalmic viscosurgical devices.
P990056/S012
5/24/11
Elecsys Total PSA ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46520
Change in manufacturing site from buildings 351/352 to building 761, all within the Roche Penzberg, Germany facility for production of a component (biotinylated- and ruthenium-labeled antibodies or “conjugated antibodies”) used in this assay.
P000006/S023
5/25/11
Titan Inflatable Penile ProsthesisColoplast Corporation
Minneapolis, MN
55411
Manufacturing contractor change of a component.
P000027/S010
5/24/11
Elecsys Free PSA ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46520
Change in manufacturing site from buildings 351/352 to building 761, all within the Roche Penzberg, Germany facility for production of a component (biotinylated- and ruthenium-labeled antibodies or “conjugated antibodies”) used in this assay.
 
P000044/S026
5/11/11
VITROS Immunodiagnostic Products HBsAg Reagent Pack & CalibratorOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Change in the process of preparing antifoam solution and the storage conditions of prepared antifoam solution.
P010013/S035
5/10/11
NovaSure Impedance Controlled Endometrial Ablation SystemHologic, Inc.
Marlborough, MA
01752
Relocation of a cable assembly process.
P010015/S113
5/5/11
Syncra CRT-P and Consulta CRT-PMedtronic, Inc.
Mounds View, MN
55112
The subject devices are able to be manufactured using new plating lines at the qualified supplier.
P010015/S114
5/5/11
Consulta and Syncra Families of CRT-PsMedtronic, Inc.
Mounds View, MN 55112
Moving sterilization equipment within a facility and implementation of a bar code reader system.
P010015/S115
5/5/11
Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN 55112
Change to an epoxy dispenser parameter, the implementation of a software revision for a laser bonder, and an update to the sterile packaging operation process.
P010015/S116
5/13/11
Consulta and Syncra Families of CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Multiple changes including a component supplier and inspection change, changes to an in-process device tester, and a change to an inspection test method.
P010015/S117
5/13/11
Consulta and Syncra Families of CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Multiple manufacturing changes including a component test method update, implementation of a new component cleaning process, and implementation of additional labeling equipment and software.
P010015/S118
5/18/11
Consulta CRT-P and Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Changes to the cleaning process performed on hybrid components.
P010015/S120
5/23/11
Consulta CRT-P and Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Alignment of process software versions.
P010015/S121
5/19/11
Attain, Consulta CRT-P, InSync III and Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P010019/S023
5/11/11
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended WearCIBA VISION Corporation
Duluth, GA
30097
Raw material test method change.
P010019/S024
5/18/11
Lotrafilcon B Soft Contact LensesCIBA VISION Corporation
Duluth, GA
30097
Change in the Secondary Packaging Side Laser Printing Inspection System.
P010031/S243
5/5/11
Protecta CRT-D and XT CRT-DMedtronic, Inc.
Mounds View, MN
55112
The subject devices are able to be manufactured using new plating lines at the qualified supplier.
P010031/S244
5/5/11
Protecta and Protecta XL Families of CRT-DsMedtronic, Inc.
Mounds View, MN 55112
Moving sterilization equipment within a facility and implementation of a barcode reader system.
P010031/S245
5/5/11
Protecta and Protecta XT Families of CRT-DsMedtronic, Inc.
Mounds View, MN 55112
Multiple manufacturing changes to the assembly line, equipment improvement and parameters, process monitoring, and laboratory analysis.
P010031/S246
5/5/11
Protecta CRT-D, Protecta XT CRT-DMedtronic, Inc.
Mounds View, MN 55112
Change to an epoxy dispenser parameter, the implementation of a software revision for a laser bonder, and an update to the sterile packaging operation process.
P010031/S247
5/13/11
Protecta and Protecta XT Families of CRT-DsMedtronic, Inc.
Mounds View, MN
55112
Multiple changes including a component supplier and inspection change, changes to an in-process device tester, and a change to an inspection test method.
P010031/S248
5/13/11
Protecta and Protecta XT Families of CRT-DsMedtronic, Inc.
Mounds View, MN
55112
Multiple manufacturing changes including a component test method update, implementation of a new component cleaning process, and implementation of additional labeling equipment and software.
P010031/S250
5/23/11
Protecta CRT-D and Protecta XT CRT-DMedtronic, Inc.
Mounds View, MN
55112
Alignment of process software versions.
P010031/S251
5/19/11
Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II and Protecta/Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P010031/S253
5/26/11
InSync Sentry CRT-D, Concerto lCD, Consulta CRT-D, Concerto II CRT-D, Maximo II CRT-D, Protecta CRT-D, and Protecta XT CRT-D.Medtronic, Inc.
Mounds View, MN
55112
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging.
P010041/S027
5/5/11
Carpentier-Edwards® Supraanular (S.A.V.(R)) BioprosthesisEdwards Lifesciences, LLC Irvine, CA
92614
Addition of a third- party supplier of the molded silicone inserts used in the devices.
P010054/S013
5/4/11
Elecsys Anti-HBs ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46250
Change to increase production capacity for a component common to all devices.
P020009/S073
5/4/11
Express and Express 2 Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Automation of the packaging and verification process.
P020018/S038
5/17/11
Zenith AAA Endovascular GraftCook Incorporated
Bloomington, IN
47404
Alternate supplier of graft material.
P020047/S034
5/12/11
VISION RX, VISION OTW, Mini VISION RX, Mini VISION OTW, and Multi Link 8 RX Coronary Stent SystemsAbbott Vascular
Temecula, CA
92591
A manual to an automated process change for packaging labeling inspection.
P030005/S075
5/5/11
Contak Renewal TRBoston Scientific Corporation CRM
St. Paul, MN
55112
Revise the electrical test software.
P030009/S055
5/12/11
Driver & Micro Driver Coronary Stent SystemsMedtronic Vascular, Inc.
Santa Rosa, CA
95403
Reduction in pyrogen testing sample size.
P030016/S020
5/4/11
STAAR Surgical Implantable Collamer Lenses for MyopiaSTAAR Surgical Company
Monrovia, CA
91016
Modification to the blocking process for the manufacture of the product lines.
P030022/S018
5/26/11
REFLECTION Ceramic Acetabular Hip SystemSmith & Nephew, Inc.
Memphis, TN
38116
Use of an alternative manufacturing supplier.
P030024/S015
5/11/11
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc CalibratorOrtho-Clinical Diagnostics, Inc. Rochester, NY
14626
Manufacturing changes being made to the device.
P030035/S081
5/3/11
Family of PacemakersSt. Jude Medical
Sunnyvale, CA
94086
Alternate plating supplier.
P030036/S028
5/12/11
Anchoring Sleeve KitMedtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test.
P030036/S029
5/18/11
SelectSecure 4 French LeadsMedtronic, Inc.
Mounds View, MN
55112
Addition of a second supplier for titanium nitride coated electrode components.
P030036/S030
5/19/11
SelectSecureMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P030054/S185
5/5/11
Epic HF/Atlas+ HF Family of CRT-DsSt. Jude Medical Sylmar, CA
91342
Addition of a secondary supplier for organic substrates.
P030054/S186
5/3/11
Family of CRT-DsSt. Jude Medical
Sunnyvale, CA
94086
Alternate plating supplier.
P030054/S187
5/11/11
Family of CRT-DsSt. Jude Medical, Inc.
Sunnyvale, CA
94086
Change in the MEMS sensor mounting material.
P040016/S071
5/4/11
VeriFLEX (Liberte) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Automation of the packaging and verification process.
P040045/S018
5/20/11
VISTAKON (senofilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Use an automated Device History Record Checklist.
P040050/S008
5/27/11
Macroplastique ImplantsUroplasty, Inc.
Minnetonka, MN
55343
Implementation of a new heat sealing instrument for final package manufacturing.
P050018/S014
5/12/11
AngioSculpt® PTCA Scoring Balloon Catheter, Rapid Exchange (RX)AngioScore, Inc. Fremont, CA
94538
Manufacturing change to include a new part number for the device and the purchase of the OEM rapid exchange balloon catheter manufactured by a qualified supplier.
P050019/S007
5/2/11
Carotid WALLSTENT® Monorail® EndoprosthesisBoston Scientific Corporation
Maple Grove, MN 55311
Several equipment upgrades, a change to the physical line layout, and introduction of automated process settings.
P050023/S044
5/6/11
Lumax Family of ICDs and CRT-DsBiotronik, Inc.
Lake Oswego, OR
97035
Addition of an inspection step during the battery manufacturing process.
P050042/S011
5/13/11
ARCHITECT Anti- HCVAbbott Laboratories Abbott Park, IL
60064
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices.
P050051/S011
5/13/11
ARCHITECT AUSABAbbott Laboratories Abbott Park, IL
60064
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices.
P060001/S012
5/26/11
Protégé GPS & Protégé Carotid Stent SystemEv3, Inc.
Plymouth, MN
55441
Optimize the ultrasonic cleaning time used in the manufacture of the device.
P060001/S013
5/17/11
Protégé GPS & Protégé RX Carotid Stent SystemEv3, Inc.
Plymouth, MN
55441
Changes in the electropolishing preparation cleaning process.
P060006/S020
5/4/11
Express SD Renal Monorail Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Automation of the packaging and verification process.
P060007/S013
5/13/11
ARCHITECT HBsAg/ ConfirmatoryAbbott Laboratories Abbott Park, IL
60064
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices.
P060008/S069
5/4/11
TAXUS Liberte Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Automation of the packaging and verification process.
P060033/S065
5/12/11
Endeavor Spring Zotarolimus-Eluting Coronary StentMedtronic Vascular, Inc.
Santa Rosa, CA
95403
Reduction in pyrogen testing sample size.
P060035/S007
5/13/11
ARCHITECT CORE-MAbbott Laboratories Abbott Park, IL
60064
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices.
P060039/S025
5/19/11
Attain StarFixMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P070006/S005
5/4/11
T-SPOT® .TB TestOxford Immunotec, Ltd.
Oxfordshire, UK
OX14 4RY
Addition of a second approved supplier of antibody coated plates for the device.
P070015/S067
5/4/11
XIENCE V & PROMUS Everolimus Eluting Coronary Stent SystemsAbbott Vascular
Temecula, CA
92591
Change to annual certification testing for an approved supplier.
P070015/S068
5/12/11
XIENCE V & PROMUS Everolimus Eluting Coronary Stent SystemsAbbott Vascular
Temecula, CA
92591
Changes to the test method for the identification and assay of antioxidant in the acceptance and stability testing of the everolimus drug substance.
P070015/S069
5/12/11
XIENCE V Everolimus Eluting Coronary Stent System and PROMUS Everolimus Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
A manual to an automated process change for packaging labeling inspection.
P070022/S018
5/10/11
Adiana Permanent Contraception SystemHologic, Inc.
Marlborough, MA
01752
The move of manufacturing lines.
P080006/S022
5/5/11
Attain Ability PlusMedtronic, Inc.
Mounds View, MN
55112
Change in aeration cycle time.
P080006/S023
5/18/11
Attain Ability LV Lead, Attain Ability Plus LV Lead and Attain Ability Straight LV LeadMedtronic, Inc.
Mounds View, MN
55112
Addition of a second supplier for titanium nitride coated electrode components.
P080006/S024
5/23/11
Attain Ability Plus and Attain Ability StraightMedtronic, Inc.
Mounds View, MN
55112
Alignment of process software versions.
P080006/S025
5/19/11
Attain Ability, Attain Ability Plus and Attain Ability StraightMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P080023/S007
5/13/11
ARCHITECT COREAbbott Laboratories Abbott Park, IL
60064
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices.
P080025/S002
5/4/11
InterStim® Neurostimulator and InterStim II NeurostimulatorMedtronic, Inc.
Minneapolis, MN 55432
Implementation of newly validated process parameters for the blister sealing machine at Medtronic Puerto Rico Operations Company (MPROC) located in Juncos, Puerto Rico.
P080025/S003
5/6/11
InterStim II Implantable NeurostimulatorMedtronic, Inc.
Minneapolis, MN
55432
Change in the testing equipment and test specifications.
P080027/S006
5/4/11
OraQuick® HCV Rapid Antibody TestOraSure Technologies, Inc.
Bethlehem, PA
18015
Automate the vial filling and capping process for the Developer Solution Vials, a component in the device.
P090003/S011
5/31/11
Express LD Iliac Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Addition of a new sterilization chamber.
P090006/S006
5/17/11
Complete SE Vascular Stent SystemMedtronic Vascular Santa Rosa, CA
95403
Extension of the scope of several activities conducted as a third party storage location.
P090007/S002
5/4/11
Elecsys Anti-HCV ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46250
Change to increase production capacity for a component common to all devices.
P090008/S002
5/4/11
Elecsys Anti-HCV ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46250
Change to increase production capacity for a component common to all devices.
P090009/S002
5/4/11
Elecsys Anti-HCV ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46250
Change to increase production capacity for a component common to all devices.
P090013/S015
5/5/11
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
The subject devices are able to be manufactured using new plating lines at the qualified supplier.
P090013/S016
5/18/11
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Changes to the cleaning process performed on hybrid components.
P090013/S017
5/19/11
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Process standardization for selected cleaning operations.
P090013/S018
5/18/11
CapSure Fix LeadMedtronic, Inc.
Mounds View, MN
55112
Addition of a second supplier for titanium nitride coated electrode components.
P090013/S020
5/19/11
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
P090013/S021
5/26/11
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging.
P090013/S022
5/26/11
Revo MRI SureScan Pacing SystemMedtronic, Inc.
Mounds View, MN
55112
Relocation of a sterilizer system within and existing location.
P100021/S008
5/17/11
Endurant Stent Graft SystemMedtronic Vascular Santa Rosa, CA
95403
Extension of the scope of several activities conducted as a third party storage location.
P100029/S001
5/16/11
Trifecta ValveSt. Jude Medical, Inc.
St. Paul, MN
55117
Addition of abattoirs for bovine tissue sourcing.
P100040/S001
5/2/11
Valiant Thoratic Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Addition of lubricant to a manufacturing process.
P100040/S002
5/17/11
Valiant Thoracic Stent Graft with Captiva Delivery SystemMedtronic Vascular Santa Rosa, CA
95403
Extension of the scope of several activities conducted as a third party storage location.
P100040/S003
5/25/11
Valiant Thoracic Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Transfer of post sterilization inspections to an alternate site.
P100040/S004
5/17/11
Valiant Thoracic Stent Graft with Captiva Delivery SystemMedtronic Vascular Santa Rosa, CA
95403
Extension of the scope of several activities conducted as a third party storage location.

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 109

Summary of PMA Originals Under Review
Total Under Review: 95
Total Active: 44
Total On Hold: 51
Number Greater Than 180 Days: 4

Summary of PMA Supplements Under Review
Total Under Review: 645
Total Active: 455
Total On Hold: 190
Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received
Originals: 2
Supplements: 95

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 109
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 153
FDA Time: 116.7 Days MFR Time: 36.3 Days