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U.S. Department of Health and Human Services

Medical Devices

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June 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
P090002
6/13/11
Pinnacle® CoMplete® Acetabular Hip SystemDePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for the Pinnacle® CoMplete® Acetabular Hip System. This device is indicated for:
The Pinnacle® CoMplete® Acetabular Hip System is a single use device intended for uncemented fixation. The Pinnacle® CoMplete® Acetabular Hip System is intended as a primary joint replacement prosthesis in total hip arthroplasty for skeletally mature patients suffering at least moderate pain in the hip joint from non-inflammatory degenerative joint
disease (NIDJD) and its composite diagnoses of osteoarthritis (OA) or post-traumatic
arthritis.
Pinnacle®" CoMplete® Acetabular Hip System's inserts (Pinnacle® Ultamet®) are only
intended for use with DePuy's femoral and acetabular components having matching outer
and inner diameters.
 
P100027
6/14/11
INFORM® HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.
Tucson, AZ
85755
Approval for the INFORM® HER2 Dual ISH DNA Probe Cocktail. This device is indicated for:
The INFORM® HER2 Dual ISH DNA Probe Cocktail is intended for use in determining HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17. The HER2 and Chromosome 17 probes are detected using two color chromogenic in situ
hybridization (ISH) in formalin-fixed. paraffin-embedded human breast cancer tissue specimens following staining on Ventana BenchMark® XT automated slide stainers (using
NeXES software), by light microscopy. The I NFORM® H ER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom I-HERPCEPTIN
(trastuzumab) treatment is being considered.
This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls.
This reagent is intended for in vitro diagnostic (IVD) use.
P100031
6/22/11
Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the MODULAR ANALYTICS E170 Immunoassay AnalyzerRoche Diagnostics Corporation
Indianapolis, IN
46250
Approval for the Elecsys® Anti-HBc Immunoassay & Elecsys® PreciControl Anti-HBc for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer. This device is indicated for the in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium-heparin, sodium-citrate, K 2 -EDTA) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. The Elecsys Anti-HBc immunoassay's performance has not been established for the monitoring HBV disease or therapy. The electro- chemiluminescence immunoassay "ECLIA" is intended for use on the MODULAR ANALYTICS EI70 Immunoassay Analyzer. The Elecsys Preci-Control Anti-HBc is used for quality control of the Elecsys Anti-HBc immunoassay on the MODULAR ANALYTICS E170
immunoassay analyzer.
P100032
6/27/11
Elecsys® Anti-HBc Immunoassay and
Elecsys® PreciControl Anti-HBc for use on the
Elecsys® 2010 Immunoassay Analyzer
Roche Diagnostics Corporation
Indianapolis, IN
46250
Approval for the Elecsys® Anti-HBc Immunoassay & Elecsys® PreciControl Anti-HBc for use on the Elecsys® 2010
Immunoassay Analyzer. This device is indicated for the in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium-heparin, sodium-citrate, K 2 -EDTA) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. The Elecsys Anti-HBc immunoassay's performance has not been established for the monitoring of HBV disease or therapy. The electrochemilumi-nescence immunoassay "ECLIA" is intended for use on the Elecsys 2010 Immunoassay Analyzer. The Elecsys PreciControl Anti-HBc is used for quality control of the Elecsys Anti-HBc immunoassay on the Elecsys 2010 immunoassay analyzer.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P820060/S027
6/10/11
180-Day
AxSYM AFPAbbott Laboratories Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P830061/S061
6/16/11
135-Day
CapSure, CapSure SP Novus, Vitatron Crystaline, Vitatron Excellence PS+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P830061/S062
6/27/11
135-Day
CapSure SP Novus Leads, CapSure, CapSure Sense Leads, Vitatron
Excellence PS+, Vitatron Crystalline
Medtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P830063/S006
6/17/11
Real-Time
PRISMAFLEX TPE 2000 SetGambro Renal Products
Lakewood, CO
80401
Approval for modifications to the Gambro Prisma TPE 2000 Set with Plasmafilter PF 2000N to permit the use of the plasmafilter with the Gambro PRISMAFLEX System. The device, as modified, will be marketed under the trade name PRISMAFLEX TPE 2000 Set and is indicated for therapeutic plasmapheresis.
P850089/S074
6/16/11
135-Day
CapSure Z Novus, CapSure SP Novus, Vitatron Excellence SS+, Vitatron Impulse II LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P850089/S075
6/27/11
135-Day
CapSure Z Novus Leads, CapSure SP Novus Leads, CapSure, Vitatron Excellence, Vitatron Excellence SS+, Vitatron Impluse II,
CapSure SP Z Leads
Medtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P880047/S015
6/17/11
Real-Time
GYNECARE INTERCEED® Absorbable Adhesion BarrierEthicon, Inc. Somerville, NJ
08876
Approval for a larger INTERCEED® product that measures 5”x6” in size. The device, as modified, is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved.
P880086/S204
6/8/11
Real-Time
Sustain XL Family of PacemakersSt. Jude Medical, Inc.
Sunnyvale, CA
94086
Approval for the new Sustain XL Pacemaker Models, predicated off
the Victory/Zephyr family of pacemaker. The device, as modified, will be marketed under the
trade name Sustain XL DR/SR and Sustain XL DC/SC and is indicated for
Indications and Usage
• Implantation of Sustain™ pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to:
• Syncope
• Presyncope
• Fatigue
• Disorientation
• Or any combination of those symptoms.
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing (Models PM2134 and PM2136 only) is indicated for those patients exhibiting:
• Sick sinus syndrome
• Chronic, symptomatic second- and third-degree AV block
• Recurrent Adams-Stokes syndrome
• Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.
Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and
intraventricular conduction systems.
Ventricular Pacing is indicated for patients with significant bradycardia and:
• Normal sinus rhythm with only rare episodes of A-V block or sinus arrest
• Chronic atrial fibrillation
• Severe physical disability.
AF Suppression (Models PM2134 and PM2136 only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.
P890003/S218
6/16/11
135-Day
CapSure VDD2, Brilliant S+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P890003/S219
6/27/11
135-Day
Prodigy lPG, Leads Wrench Kit, Leads Service Kit, Vitatron Brilliant S+, Capsure VDD Leads, Connector Port Pin-PlugMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P890055/S034
6/21/11
Special
MedStream Programmable Infusion SystemCodman & Shurtleff, Incorporated
Raynham, MA
02767
Approval to add a warning statement to the Instructions for Use.
P900061/S100
6/27/11
135-Day
Ace Header, Patch Lead, Lead End Pin CupMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.`
P910007/S023
6/8/11
180-Day
ARCHITECT Total PSAAbbott Laboratories Abbott Park, IL
60064
Approval for manufacturing site located at Abbott Ireland Diagnostic Division in Sligo, Ireland.
P910007/S025
6/10/11
180-Day
AxSYM Total PSAAbbott Laboratories Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P910007/S026
6/22/11
180-Day
ARCHITECT Total PSAAbbott Laboratories
Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Ireland Diagnostics division in Sligo, Ireland.
P910023/S257
6/21/11
180-Day
Cadence/Current/ Fortify Family of ICDsSt. Jude Medical
Sunnyvale, CA
94086
Approval for Software Model MN5000 V.5.0 for use on the Merlin.net System and Model EX2000 V.5.0 for use on Merlin@ home Devices.
P910023/S266
6/28/11
180-Day
Current Accel VR, DR ICDs and Fortify VR, DR ICDsSt. Jude Medical
Sylmar, CA
91342
Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P910073/S089
6/14/11
135-Day
Reliance IS-1 Family of LeadsBoston Scientific Corporation
St. Paul, MN
55112
Approval for acceptance of an enhancement to the insulation and tri-lumen bond process, to include an upgrade of the bonding equipment and additional acceptance activity inspections to verify an adequate bond which will prevent fluid leakage.
P910077/S115
6/21/11
Real-Time
LATITUDE Paceart Integration SystemBoston Scientific Corporation
St. Paul, MN
55112
Approval for modifications to the LATITUDE Paceart Integration (LPI) software, Model 6472 v1.01.
P920015/S074
6/27/11
135-Day
IS-l Port Pin Plug, Y Adaptor Kit, Lead Adaptor, Sprint Lead, Sprint
Quattro Lead, Sprint Quattro Secure Lead, Subcutaneous
Defibrillation Lead, Transvene SVC Lead, Tunneling Tool, Sub-Q
Lead, Sprint Quattro Single Coil
Medtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P930039/S049
6/16/11
135-Day
CapSure Fix, CapSure Fix NovusSureFix LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P930039/S050
6/27/11
135-Day
CapSureFix Novus Lead, SureFix Novus Lead, CapSureFix Lead, Vitatron Pirouet Lead, Vitatron Crystalline Actfix LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P950024/S029
6/27/11
135-Day
CapSure EPI Unipolar Lead, CapSure EPI Bipolar LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P960007/S020
6/13/11
135-Day
TransCyte Human Fibroblast-Derived Temporary Skin SubstituteAdvanced BioHealing, Inc.
La Jolla, CA
92037
Approval for modification of the automated and manual cell expansion trypsinization processes for manufacturing TransCyte.
P960013/S065
6/28/11
180-day
Tendril STS LeadSt. Jude Medical
Sylmar, CA
91342
Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P970004/S087
6/9/11
180-Day
Medtronic InterStim II NeurostimulatorMedtronic, Inc.
Minneapolis, MN
55432
Approval for design and specification changes to the Model 3058 InterStim II battery.
P970004/S116
6/8/11
Special
Medtronic InterStim® Therapy for Urinary ControlMedtronic, Inc.
Minneapolis, MN
55432
Approval for the addition of two precaution statements to the labeling of the Model 3037 patient programmer.
P970021/S030
6/13/11
135-Day
GYNECARE THERMACHOICE III Uterine Balloon Therapy SystemETHICON, Inc. Somerville, NJ
08876
Approval for changes to the catheter balloon measurement process.
P970051/S069
6/3/11
Real-Time
Nucleus 24 Cochlear Implant SystemCochlear Americas Centennial, CO 80111Approval for a modified version of the external CP810 sound processor main BTE module (approved under P970051/S049), called Build Standard D, which is primarily intended to allow for repair of the processor.
P980007/S016
6/10/11
180-Day
AxSYM Free PSAAbbott Laboratories Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P980007/S017
6/22/11
180-Day
ARCHITECT Free PSAAbbott Laboratories
Abbott Park, IL
60064
Approval for a manufacturing site located at Abbott Ireland Diagnostics division in Sligo, Ireland.
P980016/S288
6/27/11
135-Day
Marquis ICD Family, Maximo ICD Family, Intrinsic ICD Family, CapSure Lead, EnTrust ICD Family, Virtuoso ICD Family, Maximo II lCD, Secura lCD, Virtuoso ICDMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P980035/S211
6/27/11
135-Day
Sigma IPG Family, Medtronic 360 IPG Series, EnRhythm lPG, AT500 Systems, Adapta/ Versa/Sensia lPG, Relia IPGMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P980035/S227
6/2/11
Real-Time
Adapta, Versa, Sensia and Relia Implantable Pulse GeneratorsMedtronic, Inc.
Mounds View, MN
55112
Approval for an increase in gold thickness on XE263 accelerometer.
P980050/S059
6/27/11
135-Day
CS-SVC Transvene LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P990001/S086
6/27/11
135-Day
C-Series IPG, T-Series IPGMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P990056/S011
6/20/11
135-Day
 
Elecsys total PSA ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46250
Approval for a change in the manufacturing site from buildings 341, 345 and 651 to building 761, all within the Roche Penzberg, Germany facility.
P000012/S027
6/27/11
135-Day
COBAS AMPLICOR HCV Test, COBAS Ampliprep/COBAS AMPLICOR HCV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for changes to the test methods 1) magnetic susceptibility; and 2) surface area of the Tosylated magnetic beads used by the vendor.
P000027/S009
6/20/11
135-Day
Elecsys free PSA ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46250
Approval for a change in the manufacturing site from buildings 341, 345 and 651 to building 761, all within the Roche Penzberg, Germany facility.
P000053/S036
6/13/11
135-Day
AMS 800 Artificial Urinary SphincterAmerican Medical Systems, Inc.
Minnetonka, MN
55343
Approval for a new component mold.
P000053/S037
6/24/11
180-Day
AMS Sphincter 800® Urinary ProsthesisAmerican Medical Systems, Inc.
Minnetonka, MN
55343
Approval for modifications to the design specifications and manufacturing process of the AMS 800 Control Pump, a component of the AMS Sphincter 800® Urinary Prosthesis.
P010015/S111
6/16/11
135-Day
Attain LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P010015/S112
6/27/11
135-Day
InSync III CRT-P, Attain OTW Lead, Attain Bipolar OTW Lead, Attain LV LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P010031/S242
6/27/11
135-Day
InSync II Marquis lCD, InSync III Marquis lCD, InSync Marquis
lCD, InSync Sentry ICD family, InSync Maximo ICD family,
Concerto CRT-D, Maximo II CRT-D, Consulta CRT-D, Concerto II
CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P010050/S011
6/24/11
180-Day
IMMULITE® 2000 HBsAG Confirmatory KitSiemens Healthcare Diagnostics
Norwood, MA
02062
Approval for an automated means of confirmation testing on-board the IMMULITE® 2000 immunoassay analyzer. The device, as modified, will be marketed under the trade name IMMULITE® 2000 HBsAg Confirmatory Kit and is indicated for:
IMMULITE 2000 HBsAg Confirmatory is intended for in vitro diagnostic use with
IMMULITE 2000 analyzers in conjunction with the IMMULITE 2000 HBsAg assay - for
the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum or plasma (EDTA, heparinized, citrate) that were repeatedly reactive when tested by the IMMULITE/ IMMULITE 1000 HBsAg assay or by the IMMULITE 2000 HBsAg assay.
P020018/S037
6/7/11
180-Day
Zenith Flex® AAA Endovascular GraftCook, Inc.
Bloomington, IN
47402
Approval to add the Zenith Spiral-Z® AAA Endovascular Graft Iliac Leg to the
existing Zenith Flex® AAA Endovascular Graft product line. The device, as modified, will be
marketed under the trade name Zenith Spiral-Z® AAA Endovascular Graft Iliac Leg and is
indicated for use with the Zenith AAA Endovascular Graft family of products, including the Zenith Flex AAA Endovascular Graft, Zenith Renu Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft, or Zenith Branch Iliac Endovascular Graft, during either a primary or
secondary procedure in patients who have adequate iliac/femoral access compatible with the
required introduction systems. The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.
P020047/S029
6/16/11
135-Day
Multi-Link Vision, Multi-Link Mini-Vision OTW and RX, Multi-Link 8, Multi-Link 8LL, Multi-Link 8 SV Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA
92590
Approval to remove a redundant receiving inspection test.
P030009/S054
6/9/11
Real-Time
Integrity Coronary Stent SystemMedtronic Vascular Santa Rosa, CA 95403Approval for addition of labeling regarding simultaneous use of the Integrity RX stent system with either another Integrity RX stent system, or with a Sprinter Legend RX balloon dilation catheter. In addition, approval to revise the MRI compatibility information in the labeling.
P030035/S084
6/28/11
180-Day
Promote Accel
CRT-D
St. Jude Medical
Sylmar, CA
91342
Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P030036/S027
6/27/11
135-Day
SelectSecure Lead, Sleeve KitMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P030054/S181
6/21/11
180-Day
Epic HF/Atlas+HF/ Promote/Unify Family of CRT-DsSt. Jude Medical
Sunnyvale, CA
94086
Approval for Software Model MN5000 V.5.0 for use on the Merlin.net System and Model EX2000 V.5.0 for use on Merlin@ home Devices.
P030054/S191
6/28/11
180-Day
Quickflex µ Leads, Unify CRT-DsSt. Jude Medical
Sylmar, CA
91342
Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P040020/S029
6/30/11
180-Day
AcrySof IQ ReSTOR IOLAlcon Research, Ltd. Fort Worth, TX
76134
Approval for a manufacturing site located at Alcon Laboratories Ireland Ltd. in Cork, Ireland.
P040048/S014
6/2/11
Special
Trilogy AB® Acetabular SystemZimmer, Inc.
Warsaw, IN
46581
Approval for adding information about MRI safety to the package insert and patient labeling.
P050011/S002
6/17/11
135-Day
ADEPT Adhesion Reduction Solution (4% Icodextrin)Baxter Healthcare Corporation
McGaw Park, IL
60085
Approval to implement the assay for detecting the amount of peptidoglycan (PG) in the Icodextrin Active Pharmaceutical Ingredient (API).
P050012/S037
6/3/11
Real-Time
DexCom Seven and Seven Plus Continuous Glucose Monitoring SystemsDexCom, Inc.
San Diego, CA 92121
Approval for replacement of an obsolete LCD in the receiver assembly with a similar component and minor modifications to the receiver firmware to accommodate the new hardware.
P050028/S011
6/24/11
135-Day
COBAS AmpliPrep/ COBAS TaqMan HBV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for an addition of a second sintering oven for the manufacture of the bulk Magnetic Glass Particle (MGP) raw material used in the production of the MPG reagent.
P050042/S012
6/1/11
180-Day
ARCHITECT Anti-HCVAbbott Laboratories
Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P050046/S009
6/29/11
135-Day
ACUITY™ Steerable Stylet AccessoryBoston Scientific Corporation
St. Paul, MN
55112
Approval for acceptance of a change to relocate a sensor on wire grinding equipment and formalize inspections as acceptance activities.
P050051/S012
6/1/11
180-Day
ARCHITECT AUSABAbbott Laboratories
Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P060003/S005
6/9/11
Real-Time
Abbott AxSYM AUSABAbbott Laboratories
Abbott Park, IL
60064
Approval for changes to the manufacturing and quality control testing for AxSYM AUSAB Calibrators, Controls, and Reagents.
P060007/S014
6/1/11
180-Day
ARCHITECT HBsAg/
Confirmatory
Abbott Laboratories
Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P060033/S064
6/2/11
180-Day
Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemsMedtronic Vascular
Santa Rosa, CA
95403
Approval for changes to the instructions for use (with the latest available follow-up clinical data from the Endeavor clinical trial programs).
P060035/S008
6/1/11
180-Day
ARCHITECT CORE-MAbbott Laboratories
Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P060039/S023
6/16/11
135-Day
Attain StarFix LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P060039/S024
6/27/11
135-Day
Attain StarFix LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P070015/S058
6/16/11
135-Day
XIENCE V and Promus Everolimus Eluting Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA
92590
Approval to remove a redundant receiving inspection test.
P070026/S001
6/7/11
180-Day
Ceramax Ceramic Total Hip SystemDePuy, Inc.
Warsaw, IN
46581
Approval of post-approval study protocol.
P080004/S007
6/15/11
Real-Time
iSert®Hoya Surgical Optics, Inc.
Chino Hills, CA
91709
Approval for packaging changes to the Model PY-60AD. The device, as modified, will be marketed under the trade name iSert® Model PY-60ADC and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
P080006/S021
6/27/11
135-Day
Attain Ability LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P080023/S008
6/1/11
180-Day
ARCHITECT COREAbbott Laboratories
Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P080025/S008
6/10/11
Special
Medtronic® InterStim® Therapy SystemMedtronic, Inc. Minneapolis, MN
55432
Approval for changes to the labeling for the 3037 Patient Programmer to add new precautions relating to modification of the device and the effect of electromagnetic interference (EMI) on the patient programmer’s ability to communicate with the neurostimulator.
P080032/S005
6/10/11
180-Day
Alair® Bronchial Thermoplasty SystemAsthmatx, Inc.
Sunnyvale, CA
94089
Approval for a manufacturing site located at Asthmatx, Inc. in Sunnyvale, California.
P080032/S007
6/21/11
180-Day
Alair® Bronchial Thermoplasty SystemBoston Scientific Corporation
Sunnyvale, CA
94089
Approval of the post approval study protocol.
P090013/S010
6/16/11
135-Day
CapSure Fix MRI LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P090013/S011
6/27/11
135-Day
Revo IPG, Revo MRI LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for the change of the cleaning control area and the associated processes.
P100010/S010
6/28/11
Real-Time
Arctic Front® Cardiac Cryoablation CatheterMedtronic CryoCath, LP
Eagan, MN
55123
Approval for changes to the labeling to include compatibility for use with the Medtronic Achieve Mapping Catheter.
P100018/S001
6/27/11
180-Day
Pipeline Embolic DeviceChestnut Medical Technologies, Inc.
Meno Park, CA
94025
Approval of 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/S056
6/10/11
VISTAKON (etafilcon A) and (senofilcon) Brand Contact LensesVision Care, Inc.
Jacksonville, FL
32256
Replacement of a Differential Scanning Calorimeter (DSC) for a previous model that is no longer supported by the same manufacturer.
N18033/S057
6/8/11
VISTAKON (etafilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Evaluation of the automation of the repackaging activities conducted by a qualified supplier.
N18033/S058
6/16/11
VISTAKON (etafilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Change in the software for processing laboratory data related to the VISTAKON® (etafilcon A) Brand and VISTAKON® (senofilcon A) Brand Contact Lenses.
N18033/S059
6/22/11
VISTAKON (etafilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Use an electronic Raw Material Tracking System.
P820003/S106
6/10/11
Disposable CoverMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P820021/S033
6/8/11
Vifilcon A Soft Contact Lenses for Extended WearCIBA VISION Corporation
Duluth, GA
30097
Change the Alternate Raw Material Sourcing for (Vifilcon A formulation) Soft Contact Lens Materials.
P830060/S069
6/17/11
Tachy AdapterBoston Scientific Corporation
St. Paul, MN
55112
Alternate ingredient for the adhesive used in sterile packaging.
P830061/S065
6/10/11
CapSure and Vitatron Excellence+Medtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P840001/S186
6/16/11
Restore Family of Implantable Neurostimulators, Itrel 3 Implantable Neurostimulator,
Synergy Family of Implantable Neurostimulators,
Specify Surgical Leads,
Hinged 2X4 Surgical Leads,
Resume Surgical Leads,
SymMix Surgical Leads,
1X8 Lead Family, Pisces Lead Family, Quadripolar Extensions, 1X8 Extensions,
1X8 Synergy Extensions,
Low Profile Quadripolar, Extensions, Accessories and Accessory Kits for use with Spinal Cord Stimulation Devices, Adaptors and
Control Magnet
Medtronic, Inc.
Minneapolis, MN
55432
Implement or change software used for manufacturing of several devices.
P840001/S187
6/17/11
7425 Itrel 3 IPG, 7427 Synergy IPG, 7427V Synergy Versitrel IPG, 37701
RestorePrime INS, 37702 PrimeAdvanced INS, 37711 Restore INS, 37712 RestoreUltra INS, and 37713 RestoreAdvanced INS
Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of an ethylene oxide sterilizer system.
P840001/S188
6/22/11
Intrel 3, Synergy FamilyMedtronic Neuromodulation
Minneapolis, MN
55432
Addition of an alternate qualified supplier for components used in the feedthrough assembly.
P850089/S077
6/10/11
CapSure SP Z Leads, Vitatron Impulse, Vitatron Excellence S+, Vitratron Excellence SS+ and Vitatron Impulse IIMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P860004/S152
6/16/11
Synchromed II Implantable Infusion Pumps, Intra-arterial Vascular Catheters, InDura IP Intrathecal Catheters, Intrathecal Catheters, Refill Kits, Sutureless Pump Connector Revision Kits,
Proximal Catheter Revision Kits, Distal Catheter Revision Kits, Accessories and Accessory Kits for use with Programmable Infusion
Pumps, Intraspinal Trial Kits and Programmer Power Adaptor
Medtronic, Inc.
Minneapolis, MN
55432
Implement or change software used for manufacturing of several devices.
P860022/S058
6/22/11
Boston Equalens/Equalens IIBausch & Lomb Incorporated
Rochester, NY
14609
Alternate supplier of 0.2 micron formulation filter.
P880047/S016
6/30/11
GYNECARE INTERCEED Absorbable Adhesion BarrierEthicon, Inc.
Somerville, NJ
08876
Alternative cycle parameters for the manufacturing process.
P890003/S223
6/8/11
Prodigy IPGMedtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P890003/S224
6/9/11
Prodigy IPGMedtronic, Inc.
Mounds View, MN
55112
Addition of an ethylene oxide (EtO) sterilizer system.
P890003/S225
6/10/11
CapSure (Drug Eluting), ECG CableMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P900060/S042
6/30/11
Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP), Carbo-Seal Valsalva Ascending Aortic Prosthesis, Orbits Prosthetic Heart Valve, OptiFoam Prosthetic Mitral Heart ValveSorin Group USA, Inc.
Arvada, CO
80004
Change of a supplier for lock wire components.
P900060/S043
6/30/11
Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP), Carbo-Seal Valsalva Ascending Aortic Prosthesis, Orbits Prosthetic Heart Valve, OptiFoam Prosthetic Mitral Heart ValveSorin Group USA, Inc.
Arvada, CO
80004
Analytical services supplier change.
P900060/S044
6/30/11
Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP), Carbo-Seal Valsalva Ascending Aortic Prosthesis, Orbits Prosthetic Heart Valve, OptiFoam Prosthetic Mitral Heart ValveSorin Group USA, Inc.
Arvada, CO
80004
Addition of a new Optical OGP SmartScope System to an existing component inspection.
P900061/S103
6/10/11
Upsizing Sleeve for HV Lead DF-1, Upsizing Sleeve, Epicardial Patch LeadsMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P910001/S048
6/8/11
ELCA Coronary Artherectomy CathetersSpectranetics Corporation
Colorado Springs, CO
80921
Addition of an alternate supplier for a device component.
P910007/S030
6/24/11
ARCHITECT Total PSAAbbott Laboratories
Abbott Park, IL
60064
Change in the quality control testing used on an incoming raw material and a finished accessory used in ARCHITECT Total PSA and ARCHITECT Free PSA Assays.
P910073/S097
6/2/11
Endotak Reliance EZ, Endotak Reliance RX, Endotak Reliance
4-site EZ and Endotak Reliance 4-site RX Leads
Boston Scientific Corporation
St. Paul, MN
55112
Reduction in sample size.
P910073/S098
6/17/11
ENDOTAK Lead, ENDOTAK RELIANCE Lead, ENDOTAK Endurance Lead Brady Adapter, and Tachy AdapterBoston Scientific Corporation
St. Paul, MN
55112
Alternate ingredient for the adhesive used in sterile packaging.
P910077/S116
6/17/11
ENDOTAK Lead, Tachy AdapterBoston Scientific Corporation
St. Paul, MN
55112
Alternate ingredient for the adhesive used in sterile packaging.
P920015/S077
6/10/11
Transvene SVC LeadMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P930029/S030
6/10/11
RF Marinr, RF Marinr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, RF ConactrMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P930039/S053
6/10/11
Vitatron Pirouet/S+, Vitatron Crystalline ActFix, CapSureMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P930039/S055
6/29/11
CapSureFix and Crystalline Act FixMedtronic, Inc.
Mounds View, MN
55112
A lead assembly crimping process improvement.
P950020/S044
6/30/11
Flextome® Cutting Balloon® Dilation DeviceBoston Scientific Corporation
Maple Grove, MN
55311
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.
P960006/S031
6/17/11
FLEXTEND LeadBoston Scientific Corporation
St. Paul, MN
55112
Alternate ingredient for the adhesive used in sterile packaging.
P960009/S116
6/16/11
Activa Family of Implantable Neurostimulators, Soletra Implantable Neurostimulator,
Kinetra Implantable Neurostimulator, Leads,
Stereotactic Frame Lead Kit
Extensions, Adaptors, Accessory Kits used with Deep Brain Stimulation, Control Magnet
Medtronic, Inc.
Minneapolis, MN
55432
Implement or change software used for manufacturing of several devices.
P960009/S117
6/17/11
7426 Soletra INS, 7428 Kinetra INS, 37601 Activa PC INS, 37602 Activa
SC INS, 37603 Activa SC INS, and 37612 Activa RC INS
Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of an ethylene oxide sterilizer system.
P960009/S118
6/22/11
Activa SC, Soletra, KinetraMedtronic Neuromodulation
Minneapolis, MN
55432
Addition of an alternate qualified supplier for components used in the feedthrough assembly.
P960040/S244
6/17/11
CONFIENT PG, VENTAK PRIZM PG, VITALITY PG, TELIGEN PGBoston Scientific Corporation
St. Paul, MN
55112
Alternate ingredient for the adhesive used in sterile packaging.
P960042/S030
6/8/11
SLS Spectranetics Laser SheathsSpectranetics Corporation
Colorado Springs, CO
80921
Addition of an alternate supplier for a device component.
P970003/S127
6/3/11
VNS Therapy System Pulse GeneratorCyberonics
Houston, TX
77058
Make changes to software used in an electrical testing system.
D970003/S129
6/17/11
INSIGNIA PG, ALTRUA PGBoston Scientific Corporation
St. Paul, MN
55112
Alternate ingredient for the adhesive used in sterile packaging.
P970004/S113
6/16/11
Interstim Family of Implantable Neurostimulators
Leads, Extension, Test Stimulation Lead, Test Stimulation Kit, Accessories and Accessory Kits for use with Interstim therapy and
Control Magnet
Medtronic, Inc.
Minneapolis, MN
55432
Implement or change software used for manufacturing of several devices.
P970004/S114
6/17/11
3023 InterStim INS and 3058 InterStim II INSMedtronic Neuromodulation
Minneapolis, MN
55432
Addition of an ethylene oxide sterilizer system.
P970004/S115
6/22/11
InterStim FamilyMedtronic Neuromodulation
Minneapolis, MN
55432
Addition of an alternate qualified supplier for components used in the feedthrough assembly.
P970012/S085
6/10/11
Kappa 400 IPGMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P970027/S014
6/22/11
AxSYM Anti-HCVAbbott Laboratories
Abbott Park, IL
60064
Modification to a supplier of the antifoam solution used in AxSYM Anti-HCV.
P970037/S006
6/24/11
AutoDELFIA/DELFIA Xpress hAFP Test SystemPerkinElmer, Inc. Waltham, MA 02451Change in the TOPO (Trioctylphosphine oxide) raw material type used in the manufacturing of the DELFIA Inducer.
P970051/S071
6/15/11
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Change from a manual assembly to an automated assembly of the case of the sound processor battery pack.
P970051/S076
6/15/11
 
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Extension of the cure time in the moulding process.
P970051/S077
6/15/11
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Changes to the production of the solid ball assembly electrode.
P980006/S019
6/10/11
Bausch & Lomb PureVision (balafilcon A) Soft Contact LensesBausch & Lomb, Incorporated
Rochester, NY
14609
Upgrade the Cognex software for the automated Wet Vision Automated Inspection System (AIS) to Version 4.4.
P980007/S021
6/24/11
ARCHITECT Free PSAAbbott Laboratories
Abbott Park, IL
60064
Change in the quality control testing used on an incoming raw material and a finished accessory used in ARCHITECT Total PSA and ARCHITECT Free PSA Assays.
P980016/S300
6/8/11
Secura DR/VR t Virtuoso II DR /VR, Maximo II DR/VR t EnTrust,
Virtuoso, Maximo, Intrinsic, Protecta, and Protecta XT Families of
ICDs
Medtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P980016/S301
6/9/11
Entrust, Intrinsic, Marquis, Maximo, Maximo II, Maximo II M4, Protecta XT/ Protecta, Protecta XT M4, Protecta M4, Secura, Secura M4, Virtuoso, Virtuoso II ICDsMedtronic, Inc.
Mounds View, MN
55112
Addition of an ethylene oxide (EtO) sterilizer system.
P980016/S302
6/10/11
Protecta DR, Protecta VR, Protecta XT DR and Protecta XT VR ICDsMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P980035/S224
6/8/11
Adpta/Versa/Sensia, Sigma, Relia, Advisa DR, EnRythm Families of
IPGs
Medtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P980035/S225
6/9/11
Adapta, Advisa, EnRhythm, Relia, Sensia, Versa IPGsMedtronic, Inc.
Mounds View, MN
55112
Addition of an ethylene oxide (EtO) sterilizer system.
P980035/S226
6/10/11
Advisa DR IPGMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P980035/S229
6/22/11
Advisa IPGMedtronic, Inc. Mounds View, MN
55112
Changes to testing software.
P980037/S037
6/8/11
AngioJet Rheolytic Thrombectomy SystemMedrad, Inc.
Minneapolis, MN
55433
Modification of a wiping procedure.
P990034/S022
6/16/11
Side Catheter Access Port Kits
Side Catheter Access Port Kits, bulk, Refill Kits
Refill Kits, bulk
Medtronic, Inc.
Minneapolis, MN
55432
Implement or change software used for manufacturing of several devices.
P010012/S267
6/17/11
EASYTRAK Lead, ACUITY Lead, CONTAK RENEWAL PG, LIVIAN ICD, COGNIS, Left Ventricular Lead AdapterBoston Scientific Corporation
St. Paul, MN
55112
Alternate ingredient for the adhesive used in sterile packaging.
P010013/S036
6/29/11
NovaSure Impedance Controlled EndometrialHologic, Inc.
Marlborough, MA
01752
Change in manufacturing materials.
P010015/S122
6/8/11
Syncra and Consulta CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P010015/S123
6/9/11
Consulta/Syncra CRT-PSMedtronic, Inc.
Mounds View, MN
55112
Addition of an ethylene oxide (EtO) sterilizer system.
P010015/S124
6/10/11
Syncra and Consulta CRT-PMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P010015/S127
6/22/11
Consulta CRT-P, Syncra
CRT-P
Medtronic, Inc. Mounds View, MN
55112
Changes to testing software.
P010031/S254
6/8/11
Consulta, Concerto II, Maximo II and InSync II Protect Families of
CRT-Ds; Concerto, InSync II, Marquis DR, InSync III Marquis,
InSync Marquis, InSync Maximo, and InSync Sentry Families of ICDs
Medtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P010031/S255
6/9/11
Concerto, Concerto II, Consulta, Consulta DF4, InSync II Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II, Maximo II M4, Protecta XT/ Protecta CRT-D, Protecta XT M4/ Protecta M$ CRT-DsMedtronic, Inc.
Mounds View, MN
55112
Addition of an ethylene oxide (EtO) sterilizer system.
P010031/S256
6/10/11
Protecta and Protecta XT CRT-DMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P010062/S009
6/22/11
Boston Orthokeratology Shapring Lens for Overnight WearBausch & Lomb Incorporated
Rochester, NY
14609
Alternate supplier of 0.2 micron formulation filter.
P020004/S063
6/8/11
Gore Excluder AAA EndoprosthesisW.L. Gore & Associates Inc.
Flagstaff, AR
86003
Automation of a bonding process.
P020009/S074
6/30/11
Express 2® Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.
P030005/S076
6/2/11
Contak Renewal ModelsBoston Scientific Corporation
St. Paul, MN
55112
Various changes in hybrid level test.
P030005/S077
6/17/11
CONTAK RENEWAL TR PGBoston Scientific Corporation
St. Paul, MN
55112
Alternate ingredient for the adhesive used in sterile packaging.
P030017/S120
6/16/11
Precision Spinal Cord Stimulator System, Implantable Pulse Generator Charge CoilBoston Scientific Neuromodulation Valencia, CA
91355
Addition of an alternate qualified supplier for components used in assembly of the device.
P030026/S023
6/14/11
 
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and CalibratorOrtho-Clinical Diagnostic, Inc.
Rochester, NY
14626
Manufacturing process change for the manufacture and storage of the antifoam solution used in the VITROS Anti-HBc IgM Conjugate Reagent.
P030050/S010
6/14/11
Sculptra and Sculptra Aesthetic (infectable poly-L- lactic acid)Sanofi-Aventis U.S., Inc.
Bridgewater, NJ
08807
Change the location of the Design Control Center for Sculptra and Sculptra Aethetic from Sanofi Aventis U.S. LLC, Bridgewater, New Jersey to Anagni Italy.
P030052/S007
6/1/11
UroVysion Bladder Cancer Kit AssayAbbott Molecular, Inc.
Des Plaines, IL
60018
Implementation of process change to the manufacture of the FISH DNA bulk probe solution, including a new fISH DNA extraction process, a new sonication equipment, a new amination/labeling procedure, and a supplemental DNA purification processing step to reduce RNA carry-over.
P040002/S032
6/30/11
Powerlink Stent with IntuiTrak Delivery SystemEndologix, Inc.
Irvine, CA
92618
Alternate supplier of suture material.
P040014/S017
6/6/11
Therapy, Therapy Bi-Directional and Therapy 4 mm Thermistor Cardiac Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Implement an additional manufacturing rework step.
P040016/S072
6/30/11
VeriFLEX™ Bare-Metal Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.
P040042/S022
6/6/11
Therapy Dual 8, Therapy 8mm Thermistor and Safire TX Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Implement an additional manufacturing rework step.
P040045/S019
6/10/11
VISTAKON® (etafilcon A) and (senofilcon) Brand Contact LensesVision Care, Inc.
Jacksonville, FL
32256
Replacement of a Differential Scanning Calorimeter (DSC) for a previous model that is no longer supported by the same manufacturer.
P040045/S020
6/8/11
VISTAKON® (senofilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Evaluation of the automation of the repackaging activities conducted by a qualified supplier.
P040045/S021
6/16/11
VISTAKON® (senofilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Change in the software for processing laboratory data related to the VISTAKON® (etafilcon A) Brand and VISTAKON® (senofilcon A) Brand Contact Lenses.
P040045/S022
6/15/11
VISTAKON (senofilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Addition of a cure tunnel lane.
P040045/S023
6/22/11
VISTAKON (senofilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Use an electronic Raw Material Tracking System.
P050042/S013
6/24/11
ARCHITECT ANTI-HCVAbbott Laboratories Abbott Park, IL
60064
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P050046/S011
6/17/11
ACUITY LeadBoston Scientific Corporation
St. Paul, MN
55112
Alternate ingredient for the adhesive used in sterile packaging.
P050051/S013
6/24/11
ARCHITECT AUSABAbbott Laboratories Abbott Park, IL
60064
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P060001/S014
6/27/11
Protégé GPS & Protégé RX Carotid Stent SystemEv3 Endovascular Inc.
Plymouth, MN
55441
Alternate etching process for sphere components.
P060007/S015
6/24/11
ARCHITECT HBsAg, ARCHITECT HBsAg ConfirmatoryAbbott Laboratories Abbott Park, IL
60064
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P060008/S071
6/30/11
TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent SystemsBoston Scientific Corporation
Maple Grove, MN
55311
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.
P060010/S009
6/14/11
The Spanner Temporary Prostatic StentAbbeyMoor Medical, Inc.
Parkers Prairie, MN
56351
Minor formulation change in a raw material.
P060022/S011
6/8/11
Akreos Posterior Chamber Intraocular LensBausch & Lomb Inc.
Aliso Viejo, CA
92656
Addition of an alternate facility as a source or the Akreos lens button and an alternate supplier of methyl methacrylate.
P060035/S009
6/24/11
ARCHITECT CORE-MAbbott Laboratories Abbott Park, IL
60064
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P080006/S026
6/2/11
Attain Ability Family of LeadsMedtronic, Inc.
Mounds View, MN
55112
Addition of an additional testing laboratory for sterilization.
P080006/S027
6/8/11
Attain AbilityMedtronic, Inc.
Mounds View, MN
55112
Update to the sterile packaging operation process.
P080006/S028
6/10/11
Attain Ability Plus, Attain Ability StraightMedtronic, Inc. Mounds View, MN
55112
Change the cleaning area of the devices.
P080014/S008
6/23/11
Cervista® Papilloma Virus (HPV) High Risk (HR)Hologic LP
Marlborough, MA
01752
Addition of a new supplier of Bovine Serum Albumin (BSA).
P080015/S004
6/23/11
Cervista® Human Papilloma Virus (HPV) 16/18Hologic LP
Marlborough, MA
01752
Addition of a new supplier of Bovine Serum Albumin (BSA).
P080023/S009
6/24/11
ARCHITECT COREAbbott Laboratories Abbott Park, IL
60064
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P080025/S005
6/16/11
Interstim Family of Implantable Neurostimulators,
Leads, Extension, Test Stimulation Lead, Test Stimulation Kit, Accessories and Accessory Kits for use with Interstim therapy and
Control Magnet
Medtronic, Inc.
Minneapolis, MN
55432
Implement or change software used for manufacturing of several devices.
P080025/S006
6/17/11
InterStim INS and 3058 InterStim II INSMedtronic Neuromodulation
Minneapolis, MN
55432
Addition of an ethylene oxide sterilizer system.
P080025/S007
6/22/11
InterStim FamilyMedtronic Neuromodulation
Minneapolis, MN
55432
Addition of an alternate qualified supplier for components used in the feedthrough assembly.
P090013/S023
6/8/11
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P090013/S024
6/9/11
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Addition of an ethylene oxide (EtO) sterilizer system.
P090013/S026
6/29/11
CapSureFix MRIMedtronic, Inc.
Mounds View, MN
55112
A lead assembly crimping process improvement.
P100023/S001
6/7/11
Ion (Taxus Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Changes to your cut-to-length process during catheter assembly.
P100023/S004
6/29/11
Ion (Taxus Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Changes to the proximal Heat Shrinking Removal Inspection Process.

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 78

Summary of PMA Originals Under Review
Total Under Review: 93
Total Active: 35
Total On Hold: 58
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 691
Total Active: 501
Total On Hold: 190
Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received
Originals: 3
Supplements: 98

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 78
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 116.2
FDA Time: 93.3 Days MFR Time: 22.9 Days