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U.S. Department of Health and Human Services

Medical Devices

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August 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
P100044
8/11/11
Propel™Intersect ENTApproval for the Propel™ sinus implant. This device is indicated for use in patients ≥ 18 years of age following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. The Propel™ sinus implant separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema.
P110012
8/26/11
Vysis ALK Break Apart FISH Probe Kit; Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit; ProbeChek ALK Negative Control Slides; and ProbeChek
ALK Positive Control Slides
Abbott Molecular, Inc.
Des Plaines, IL
60018
Approval for the Vysis ALK Break Apart FISH Probe Kit; Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit; ProbeChek ALK Negative Control Slides; and ProbeChek ALK Positive Control Slides. This device is indicated for:
The Vysis ALK Break Apart FISH Probe Kit
is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin -embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with Xalkori® crizotinib). The test is for prescription use only.
The Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit is used to prepare paraffin-embedded lung cancer tissue sections fixed on positively charged slides for use in fluorescence in situ hybridization (FISH) with Vysis DNA FISH probes.
The ProbeChek ALK Negative Control Slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020). The ProbeChek ALK Negative Control Slides should be assayed in conjunction with the user's specimen slides according the package insert for the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020).
The ProbeChek ALK Positive Control Slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020). The ProbeChek ALK Positive Control Slides should be· assayed in conjunction with the user's specimen slides according the package insert for the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020).
P110020
8/17/11
cobas® 4800 BRAF V600 Mutation TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for the cobas® 4800 BRAF V600 Mutation Test. This device is indicated for: The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of the BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P810002/S076
8/11/11
Real-Time
St. Jude Medical® Mechanical Heart Valve: SJM® Masters Series – PTFE Sewing CuffSt. Jude Medical
St. Paul, MN
55117
Approval for changes to the specification range for the courses per inch (CPI) and thickness of the PTFE fabric used in the construction of the PTFE sewing cuff used with the Masters Series Valves, as well as approval of two changes intended to offset the increase in the force required for valve rotation (torque) associated with the fabric modification. These proposed changes are for the increase in the diameter of the rotation spring and retainer ID and reducing the lower limit of torque from 2.0 in-oz to 0.2
in-oz.
P840001/S195
8/26/11
Special
RestorePrime, Prime Advanced, Restore, RestoreUltra, RestoreAdvanced, Itrel 3, Synergy, and Synergy Versitrel Implantable Neurostimulators (INS)Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P850022/S018
8/11/11
Real-Time
Biomet ® OrthoPak® Non-Invasive Bone Growth Stimulator System and the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator SystemEBI, L.P.
Parsippany, NJ
07054
Approval for the modification of the system software to include an additional line of code which would allow the real-time clock to reset to “day zero” after an
elapsed 365 days. This reset would allow your device to remain functional after 365 days of
inactivity. The device, as modified, will be marketed under the trade names OrthoPak® Non-Invasive
Bone Growth Stimulator System and SpinalPak Non-Invasive Spine Fusion Stimulator
System and are indicated for the following:
1) The Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half
the width of the bone to be treated. A nonunion is considered to be established when the
fracture site shows no visible progressive signs of healing; and
2) The Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
P860004/S157
8/26/11
Special
SynchroMed II and SynchroMed EL Implantable Infusion PumpMedtronic Neuromodulation
Minneapolis, MN 55432
Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P880006/S071
8/3/11
180-Day
Sensolog, Dialog and Regency Family of PacemakersSt. Jude Medical, Cardiac Rhythm Management
Sylmar, CA
91342
Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P880006/S072
8/17/11
Real-Time
St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D DevicesSt. Jude Medical Cardiac Rhythm Management
Sunnyvale, CA
94086
Approval for minor modifications to the patient manuals packaged with the devices.
P880086/S198
8/2/11
135-Day
Affinity, Integrity, Victory, Zephyr and Accent Families of PacemakersSt. Jude Medical
Cardiac Rhythm Management
Sylmar, CA
91342
Approval for additional manufacturing screening tests for a device component.
P880086/S203
8/3/11
180-Day
Affinity, Integrity, Victory, Zephyr and Accent Family of PacemakersSt. Jude Medical, Cardiac Rhythm Management
Sylmar, CA
91342
Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P880086/S206
8/11/11
Real-Time
Accent Family of PacemakersSt. Jude Medical
Cardiac Rhythm Management
Sylmar, CA
91342
Approval for modifications to the hybrid used in the devices.
P880086/S207
8/17/11
Real-Time
St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D DevicesSt. Jude Medical Cardiac Rhythm Management
Sunnyvale, CA
94086
Approval for minor modifications to the patient manuals packaged with the devices.
P890003/S228
8/25/11
Real-time
Medtronic CareLink Express MonitorsMedtronic, Inc.
Mounds View, MN
55112
Approval for Models 2020B/C Medtronic CareLink Express Monitors and Modifications to the Model
2490G/H/J Medtronic CareLink Remote Home Monitor and Model 2020A Medtronic
CardioSight Reader to update device Firmware.
P890023/S017
8/9/11
135-Day
Biomedics UV 55% (Ocufilcon D) Sphere, Asphere and Toric Soft Contact LensCooperVision
Pleasanton, CA
94588
Approval for an alternate vendor, BIMAX, for raw material.
P900056/S104
8/31/11
180-Day
Rotablator Rotational Atherectomy System
 
Boston Scientific Corporation
Maple Grove, MN
55311
Approval for modifications to the RotaWire and Rotalink Burr/ Rotalink Plus Instructions for Use (IFU).
P910023/S256
8/2/11
135-Day
Frontier, Frontier II and Anthem Families of CRT-PsSt. Jude Medical
Cardiac Rhythm Management
Sylmar, CA
91342
Approval for additional manufacturing screening tests for a device component.
P910023/S264
8/3/11
180-Day
Cadence Family of ICDsSt. Jude Medical, Cardiac Rhythm Management
Sylmar, CA
91342
Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P910023/S267
8/17/11
Real-Time
St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D DevicesSt. Jude Medical Cardiac Rhythm Management
Sunnyvale, CA
94086
Approval for minor modifications to the patient manuals packaged with the devices.
P920047/S045
8/12/11
180-Day
Blazer Prime HTD Cardiac Ablation CathetersBoston Scientific Corporation
San Jose, CA
95134
Approval for a manufacturing site located at Boston Scientific Corporation in Heredia, Costa Rica.
P940019/S025
8/17/11
Real-Time
WALLSTENT® Iliac Endoprosthesis with Unistep™ Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for labeling changes related to the MR compatibility of the device.
P950022/S077
8/5/11
Real-Time
Connector Sleeve Accessory KitSt. Jude Medical
Sylmar, CA
91342
Approval for a connector sleeve accessory kit Model EX3151. The connector sleeve is indicated for use with IS-4 and DF-4 lead connectors to facilitate the connection to a pacing system analyzer at the time of implant.
P950029/S060
8/18/11
Real-Time
REPLY/ESPRIT SR/DR PacemakerSorin CRM USA, Inc.
Plymouth, MN 55441
Approval for the addition of the Dplus and Acceleration and Atrial Ventricular Delay Reduction pacing modes along with minor software updates.
P960009/S125
8/26/11
Special
Soletra, Kinetra, Activa PC, Activa SC and Activa RC INSMedtronic Neuromodulation
Minneapolis, MN 55432
Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P960043/S073
8/24/11
Real-Time
Prostar XL Percutaneous Vascular Surgical SystemAbbott Vascular, Inc.
Redwood City, CA
94063
Approval for changes to packaging and packaging integrity testing.
P970003/S117
8/26/11
180-Day
VNS Therapy SystemsCyberonics, Inc.
Houston, TX
77058
Approval for a manufacturing site located at Cyberonics in Austin, Texas.
P970004/S108
8/19/11
135-Day
InterStim II NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for changes to the procedure for confirming that the ultrasonic staking of two washers has been performed and a modification of a tool used to ensure the setscrew is present in the setscrew block.
P970004/S121
8/25/11
180-Day
InterStim II Implantable NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for a sterilization site located at Sterigenics US, Inc. in Queensbury,
New York .
P970004/S125
8/26/11
Special
Medtronic InterStim® Therapy for Urinary ControlMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition or precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P970013/S040
8/3/11
180-Day
Microny Family of PacemakersSt. Jude Medical, Cardiac Rhythm Management
Sylmar, CA
91342
Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P970013/S041
8/17/11
Real-Time
St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D DevicesSt. Jude Medical Cardiac Rhythm Management
Sunnyvale, CA
94086
Approval for minor modifications to the patient manuals packaged with the devices.
P970051/S070
8/30/11
135-Day
Nucleus Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Approval for a change to the diameter specification of the wire used in the electrodes of the cochlear implant system.
P970051/S074
8/30/11
135-Day
Nucleus Cochlear Implant SystemCochlear Americas Centennial, CO
80111
Approval for a change to move the inner and outer moulding process of a transformer pod in-house, and modify the shape of the inner-mould.
P970051/S082
8/19/11
135-Day
Nucleus Cochlear Implant SystemCochlear Americas Centennial, CO
80111
Approval to add inspection checks.
P980016/S298
8/18/11
180-Day
Medtronic Secura D224DRG/ D224VRC, Maximo II D284DRG/ D284VRC,
Virtuoso II D274DRG/ D274VRC, Protecta XT DR D314DRG, Protecta DR D334DRG, Protecta XT VR D314VRG, Protecta VR D334VRG
Medtronic, Inc.
Mounds View, MN
55112
Approval for design, materials, and manufacturing changes to the hybrids used in the Gen2 and Adams hybrid platforms.
P980022/S067
8/29/11
180-Day
MiniMed Continuous Glucose Monitoring SystemMedtronic, Inc.
Northridge, CA
91325
Approval for a change in the raw material used in the adhesive patch of the glucose sensor component (models MMT-7002 and MMT-7003) of the device.
P990020/S045
8/18/11
135-Day
Aneurx AAAdvantage Stent Graft with the Xcelerant Hydro Delivery SystemMedtronic Vascular Santa Rosa, CA
95403
Approval for automation of your inventory management system.
P000008/S023
8/15/11
180-Day
LAP-BAND® Adjustable Gastric Banding SystemAllergan, Inc.
Goleta, CA
93117
Approval of the post-approval study protocol.
P000010/S019
8/17/11
135-Day
AMPLICOR HCV Test, Version 2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for changes made to the acceptance criteria for a conjugate bulk solution used in the device.
P000025/S051
8/26/11
135-Day
COMBI 40+ Cochlear Implant SystemMED-EL Corporation
Durham, NC
27713
Approval for: 1) new calibration process for vacuum oven; 2) changes to transfer presses and parameters for the closing force; 3) release of new equipment used for the magnet-peel test; 4) release of new insert equipment; 5) merged 2 production systems; 6) change to a lead free solder, and glue of the microphone; 7) release of a new fixture “RTV Stander”; 8) change of battery pack test box; 9) new coating equipment and clamping device; and 10) qualification for new grinding and polishing equipment and equipment used for the vacuum impregnation of micrographs.
P000057/S006
8/26/11
135-Day
Ascension MCPAscension Orthopedics, Inc. Austin, TX
78754
Approval for a change to the coating supplier manufacturing facility.
P010012/S260
8/5/11
135-Day
Acuity Spiral Lead FamilyBoston Scientific Corporation
St. Paul, MN
55112
Approval for the following changes:
1) add an alternate Dexamethasone Acetate supplier;
2) update to DXA mixing process parameters to enhance process capability;
3) alternate analytical method to test for dosage and product degradation;
4) modification of the analytical methods to remove impurity peaks observed; and
5) add in process verification for mix homogeneity.
P010012/S268
8/5/11
Real-Time
EASYTRAK 2Boston Scientific Corporation
St. Paul, MN
55112
Approval for changes to the polyurethane tubing specifications and the addition of an alternate polyurethane tubing supplier.
P010014/S014
8/5/11
180-Day
Oxford® Unicompartmental Knee SystemBiomet Manufacturing Corporation
Warsaw, IN
46582
Approval for manufacturing sites located at Biomet Orthopedics, Inc. in Warsaw, Indiana and Steris, Inc. in Libertyville, Illinois.
P010021/S019
8/2/11
135-Day
Vitros Immunodiagnostic Products Anti-HCV Reagent Pack & CalibratorOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Approval for the replacement of a raw material, foetal calf serum, with bovine serum albumin in the formulation of the VITROS Anti-HCV conjugate reagent.
P010030/S029
8/3/11
Real-Time
LifeVest Wearable DefibrillatorsZOLL Lifecor Corporation
Pittsburgh, PA
15238
Approval for several minor hardware updates to lead-free alternate components for the devices.
P010031/S252
8/18/11
180-Day
Medtronic Consulta D224TRK, Maximo II D284TRK, Concerto II D274TRK,
Protecta XT CRT-D D314TRG, Protecta CRT-D D334TRG
Medtronic, Inc.
Mounds View, MN
55112
Approval for design, materials, and manufacturing changes to the hybrids used in the Gen2 and Adams hybrid platforms.
P010032/S040
8/12/11
Special
EON C IPG (Implantable Pulse Generator System)St. Jude Medical
Plano, TX
75024
Approval for labeling changes to include additional information regarding battery passivation in the EON C IPG Directions for Use.
P020025/S026
8/12/11
180-Day
Blazer Prime XP Cardiac Ablation CathetersBoston Scientific Corporation
San Jose, CA
95134
Approval for a manufacturing site located at Boston Scientific Corporation in Heredia, Costa Rica.
P030002/S020
8/5/11
180-Day
Crystalens® Accommodating Intraocular LensBausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval to market Crystalens® Model AT-45 Accommodating Intraocular
Lens (IOL) with a Benzotriazole ultra-violet (UV) absorber chromophore (UVAM), to be
designated as Models AT1UV, AT2UV, HD1UV, HD2UV, AO1UV and AO2UV.
P030035/S078
8/2/11
135-Day
Cadence, Current and Fortify Families of ICDsSt. Jude Medical
Cardiac Rhythm Management
Sylmar, CA
91342
Approval for additional manufacturing screening tests for a device component.
P030035/S083
8/3/11
180-Day
Frontier, Frontier II and Anthem Family of CRT-PsSt. Jude Medical, Cardiac Rhythm Management
Sylmar, CA
91342
Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P030035/S086
8/17/11
Real-Time
St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D DevicesSt. Jude Medical Cardiac Rhythm Management
Sunnyvale, CA
94086
Approval for minor modifications to the patient manuals packaged with the devices.
P030042/S004
8/8/11
Real-Time
CONSERVE® Plus Total Resurfacing Hip SystemWright Medical Technology, Incorporated
Arlington, TN
38002
Approval for the CONSERVE Plus A-Class Femoral Component and the CONSERVE Plus Thick Acetabular Shell to be used as components of the device.
P030054/S180
8/2/11
135-Day
Epic HF, Atlas+ HF, Promote and Unity Families of CRT-DsSt. Jude Medical
Cardiac Rhythm Management
Sylmar, CA
91342
Approval for additional manufacturing screening tests for a device component.
P030054/S189
8/3/11
180-Day
Epic HF and Atlas+ HF Family of
CRT-Ds
St. Jude Medical, Cardiac Rhythm Management
Sylmar, CA
91342
Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P030054/S192
8/5/11
Real-Time
Connector Sleeve Accessory KitSt. Jude Medical
Sylmar, CA
91342
Approval for a connector sleeve accessory kit Model EX3151. The connector sleeve is indicated for use with IS-4 and DF-4 lead connectors to facilitate the connection to a pacing system analyzer at the time of implant.
P030054/S193
8/17/11
Real-Time
St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D DevicesSt. Jude Medical Cardiac Rhythm Management
Sunnyvale, CA
94086
Approval for minor modifications to the patient manuals packaged with the devices.
P040003/S009
8/9/11
180-Day
ExAblate 2000/2100 1.5 and 3T Magnetic Resonance Guided Focused UltrasoundInSightec, Ltd.
Dallas, TX
75244
Approval for updated labeling including long-term data from the post-approval study.
P040043/S039
8/23/11
180-Day
GORE TAG Thoracic EndoprosthesisW.L Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for a modified version of the TAG Thoracic Endoprosthesis. The TAG Device is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy, including adequate iliac/ femoral access, aortic inner
diameter in the range of 16-42 mm, and ≥ 20 mm non-aneurysmal aorta proximal and distal to the aneurysm.
P050037/S029
8/2/11
Real-Time
Radiesse® Injectable ImplantMerz Aesthetics, Inc.
Franksville, WI
53126
Approval for the addition of a number of precautions to the Instructions for Use.
P050052/S032
8/2/11
Real-Time
Radiesse® Injectable ImplantMerz Aesthetics, Inc.
Franksville, WI
53126
Approval for the addition of a number of precautions to the Instructions for Use.
P060008/S067
8/12/11
180-Day
TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for revised labeling to include updated clinical trial data through the final 5-year time point for the TAXUS ATLAS study and through three (3) years for the TAXUS ATLAS Small Vessel and Long Lesion studies.
P070007/S029
8/18/11
135-Day
Talent Thoracic Stent Graft with the Xcelerant and Captivia Delivery SystemMedtronic Vascular Santa Rosa, CA
95403
Approval for automation of your inventory management system.
P070015/S064
8/23/11
135-Day
XIENCE V and Promus Everolimus Eluting Coronary Stent systems (EECSS)Abbott Vascular
Temecula, CA
92591
Approval for the transfer of several everolimus drug tests from a third party lab to the Abbott Vascular Technical Service Lab in Temecula, California.
P070022/S020
8/9/11
Real-Time
Adiana Permanent Contraception SystemHologic, Inc.
Marlborough, MA
01752
Approval for a change of the acceptance criteria for the deployment force exerted on a polyurethane ring in the Adiana catheter.
P070027/S029
8/18/11
135-Day
Talent Abdominal Stent Graft with the Xcelerant Hydro Delivery SystemMedtronic Vascular Santa Rosa, CA
95403
Approval for automation of your inventory management system.
P080013/S007
8/18/11
Special
DuraSeal™ Exact Spine Sealant SystemCovidien
Bedford, MA
01730
Approval for a modification to the instructions for use to instruct the surgeon in the best practices in applying the sealant.
P080025/S013
8/25/11
180-Day
InterStim II Implantable NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for a sterilization site located at Sterigenics US, Inc. in Queensbury,
New York .
P080025/S018
8/26/11
Special
Medtronic InterStim® Therapy SystemMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition or precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P100010/S001
8/23/11
180-Day
The Arctic Front Cryocatheter SystemMedtronic CryoCath
Pointe Claire, Quebec, Canada
H9R 5Z8
Approval of the post-approval study protocol.
P100018/S003
8/30/11
Special
Pipeline™ Embolization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA
92618
Approval for adding a warning about allergies to metals used in the device and clarifying your instructions for use.
P100021/S004
8/18/11
135-Day
Endurant Stent Graft SystemMedtronic Vascular Santa Rosa, CA
95403
Approval for automation of your inventory management system.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P790007/S030
8/25/11
Hancock I Low Porosity and Modified Orifice Valved ConduitMedtronic, Inc.
Santa Ana, CA
92705
Addition of a glutaraldehyde supplier.
P810031/S040
8/31/11
Sodium Hyaluronate Opthalmic Viscoelastic Devices (OVD)Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Implementation of a new Pure Steam Generator.
P820003/S109
8/4/11
Adaptor: EPG Safety Cable, Disposable CoverMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P820003/S110
8/15/11
Adaptor: EPG Safety Cable, Disposable EPG CoverMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P830061/S070
8/4/11
Capsure, Vitatron Crystaline, Vitatron Excellence +, Vitatron Excellence PS+Medtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P830061/S071
8/15/11
Capsure,
Vitatron Crystaline, Vitatron Excellence +, Vitatron Excellence PS+
Medtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P840001/S192
8/5/11
Pisces Lead, Pisces Compact Lead, Pisces Plus Lead, 1x8 Subcompact Lead 3776, 1x8 Standard Lead 3777, 1x8 Compact Lead 3778, 1x8 Subcompact Lead 3876, 1x8 Standard Lead 3877, 1x8 Compact Lead 3878, Hinged 2x4 Surgical Lead, Low Profile Quadripolar Extension, 1x8 Extension, Dual Quadripolar Extension Kit, Single Quadripolar Extension Kit, Specify Surgical Lead, Specify 2x8 Surgical Lead, Specify 5-6-5 Surgical LeadMedtronic, Inc. Minneapolis, MN 55432Changes to the blister sealing operation and the inspection specifications for that operation.
P840001/S193
8/17/11
Restore Family of Implantable Neurostimulators, Itrel 3 Implantable NeurostimulatorMedtronic, Inc.
Minneapolis, MN
55432
Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P840001/S194
8/17/11
Restore Family of Implantable Neurostimulators/ Itrel/Synergy/Family of INS/SymMix Surgical LeadMedtronic Neuromodulation
Minneapolis, MN
55432
Update the software used at several of Medtronic’s manufacturing facilities.
P850051/S077
8/4/11
Vitatron LegacyMedtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P850089/S082
8/4/11
CapSure, CapSure SP Lead, CapSure Z Novus, Vitatron Excellence S+,
Vitatron Excellence SS+, Vitatron Impulse, Vitatron Impulse II
Medtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P850089/S083
8/15/11
CapSure, CapSure Z Novus, Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse, Vitatron Impulse IIMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P860003/S060
8/5/11
THERAKOS CELLEX Photopheresis SystemTHERAKOS, Inc.
Raritan, NJ
08869
Change in supplier for a component.
P860004/S155
8/17/11
Synchromed II Implantable Infusion PumpsMedtronic, Inc.
Minneapolis, MN
55432
Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P860004/S156
8/17/11
SynchroMed II Implantable Infusion Pump/Intra-arterial Vascular Catheters/ Vascular Catheters/ InDura 1P Intrathecal Catheters/Intrathecal CatheterMedtronic Neuromodulation
Minneapolis, MN
55432
Update the software used at several of Medtronic’s manufacturing facilities.
P880047/S017
8/18/11
GYNECARE INTERCEED Absorbable Adhesion BarrierEthicon, Inc.
Somerville, NJ
08876
Addition of a new band sealer.
P890003/S232
8/4/11
Prodigy, Thera I IPGMedtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P890003/S233
8/4/11
CapSure, CapSure Model, ECG Cable, Prodigy, Service Kit-Pacemaker
Repair Kit
Medtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P890003/S234
8/15/11
CapSure, CapSure Model, ECG Cable, Prodigy, Service Kit-Pacemaker Repair KitMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P900056/S108
8/25/11
Rotablator Rotational Atherectomy SystemBoston Scientific Corporation
Maple Grove, MN
55311
Modification and rearrangement of the manufacturing process for efficiency.
P900061/S106
8/4/11
ACE, ACE HeaderMedtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P900061/S107
8/4/11
Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE, ACE 5434T, ACE header, Defibrillation Support Device, Lead End Pin Cap, Oval Patch LeadMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P900061/S108
8/15/11
Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE, ACE 5434T, ACE header, Defibrillation Support Device, Lead End Pin Cap, Oval Patch LeadMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P910023/S268
8/12/11
Fortify DR and Fortify VR ICDsSt. Jude Medical
Sylmar, CA
91342
Change in Automated Manufacturing Tests (ATE) used at the half-can level.
P910023/S269
8/15/11
Cadence Family of ICDsSt. Jude Medical
Sylmar, CA
91342
Addition of secondary suppliers for the thyristor SCR and the High Voltage/Current diode components.
P920015/S081
8/4/11
"Y" Adaptor/ Extender Kit, DF-1 Connector Port Pin Plug, IS-1 Connector
Port Pin Plug Kit, Lead Adaptor, Sprint,
Sprint Quattro, Sprint Quattro
Lead, SUBCUTANEOUS LEAD, Transvene SVC Lead, Tunneling Tool
Medtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P920015/S082
8/15/11
"Y" Adaptor/ Extender Kit, DF-1 Connector Port
Pin Plug, IS-1 Connector
Port Pin Plug Kit, Lead Adaptor, Sprint,
Sprint Quattro, Sprint Quattro
Lead, SUBCUTANEOUS LEAD, Sub-Q Defibrillation Lead, Transvene SVC Lead, Tunneling Tool
Medtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P930029/S032
8/4/11
Cable ATAKR to ECG, Conductr 5 Mm 8fr, Conductr RF MC 0786022,
Contactr Catheter 7 Fr 5 Mm (70257533), Contatr Catheter 7 Fr 5 Mm
(70256034), RF Conductr MC Self-Reference Catheter, RF Enhancr II
Ablation catheter, RF MARIN UNI 112 CM 6L, RF Marinr MC 7F 5/5/5, RF Marinr MC 7fr 112 Cm, RF Marinr MC 7fr 2-5-2, RF MARINR MC
UN 110CM, RF Marinr MCXL 5/5/5, RF Marinr MC, XI 7fr, RF Marinr
SC 5F 80CM, RF Marinr Sc XI 5fr 110cm, RF Marinr Sc Xs 5fr 110cm,
RF Marinr SCXL 5F 80CM, RF MarinrSCXXL 5F 80CM
Medtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P930029/S033
8/15/11
RF Conductr MC, RF Contactr,
RF Enhancer II,
RF Marinr MC 7f/SC 5f,
RF Marinr Unipolar, RF Conductr MC Ablation Catheters
Medtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P930031/S030
8/4/11
WALLSTENT™ (TIPS) EndoprosthesisBoston Scientific Corporation
Maple Grove, MN
55311
Alternate vendor for the distal tip component of the delivery system for the devices.
P930039/S060
8/4/11
CapSure, SureFix, Torque Clip - accessory for 5076 lead, Vitatron Crystalline ActFix, Vitatron Pirouet S+Medtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P930039/S061
8/15/11
CapSure, SureFix, Torque Clip - accessory for 5076 lead, Vitatron Crystalline ActFix, Vitatron Pirouet S+Medtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P940019/S026
8/4/11
WALLSTENT™ (Iliac) EndoprosthesisBoston Scientific Corporation
Maple Grove, MN
55311
Alternate vendor for the distal tip component of the delivery system for the devices.
P950020/S046
8/4/11
Flextome Cutting Balloon and Cutting Balloon Ultra 2Boston Scientific Corporation
Maple Grove, MN
55311
Change to the inflation manifold component inspection process.
P950024/S034
8/4/11
CapSure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P950024/S035
8/15/11
CapSure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P950029/S061
8/29/11
Reply/Esprit IPGELA Medical, Inc.
Plymouth, MN
55441
Change to the reflow soldering profile and an alternate tooling used for the passing oven.
P960009/S122
8/5/11
DBS Lead, DBS Lead - Reduced Spacing Extension, DBS ExtensionMedtronic, Inc. Minneapolis, MN 55432Changes to the blister sealing operation and the inspection specifications for that operation.
P960009/S123
8/17/11
Activa Family of Implantable Neurostimulators, Soletra Implantable Neurostimulator, Kinetra Implantable NeurostimulatorMedtronic, Inc.
Minneapolis, MN
55432
Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P960009/S124
8/17/11
Activa Family of INS/Soletra INS/ Kinetra INSMedtronic Neuromodulation
Minneapolis, MN
55432
Update the software used at several of Medtronic’s manufacturing facilities.
P960016/S037
8/4/11
Livewire TC™ Cardiac Ablation SystemSt. Jude Medical Minnetonka, MN 55345Update the UV Trimming process.
P960043/S074
8/10/11
Suture Medicated Closure Systems, Percutaneous Vascular Surgical Systems and Associated AccessoriesAbbott Vascular, Inc.
Redwood City, CA
94063
Change in BET location and technique.
P970003/S131
8/11/11
VNS Therapy® SystemCyberonics, Inc.
Houston, TX
77058
Change to modify the electrical test system software.
P970003/S132
8/4/11
VNS Therapy® System Pulse GeneratorsCyberonics, Inc.
Houston, TX
77058
Use of a new piece of equipment for a quality systems test.
P970003/S133
8/31/11
VNS Therapy®
Therapy System
Cyberonics, Inc.
Houston, TX
77058
Change to add additional testing for the flash memory cards.
P970004/S120
8/5/11
Leads 3080/3886/3889/ 3093, Lead Extension 3095Medtronic, Inc. Minneapolis, MN 55432Changes to the blister sealing operation and the inspection specifications for that operation.
P970004/S122
8/17/11
Interstim Family of Implantable NeurostimulatorsMedtronic, Inc.
Minneapolis, MN
55432
Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P970004/S123
8/17/11
InterStim Family of INSMedtronic Neuromodulation
Minneapolis, MN
55432
Update the software used at several of Medtronic’s manufacturing facilities.
D970012/S087
8/25/11
AMS Ambicor Penile ProsthesisAmerican Medical Systems
Minnetonka, MN
55343
Replacement mold insert.
P970012/S088
8/4/11
Kappa 400 IPGMedtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P970020/S066
8/10/11
MultiLink Zeta Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Change to a component in-process inspection.
P970031/S034
8/25/11
Freestyle Aortic Root BioprosthesisMedtronic, Inc.
Santa Ana, CA
92705
Addition of a glutaraldehyde supplier.
P970055/S011
8/3/11
Biotrin International’s Parvovirus B19 IgM Enzyme ImmunoassayBiotrin International Ltd.
Dublin, Ireland
Manufacturing process change for preparation of the Sensitivity Standards, used as a reference material to establish the cut-off value for the device.
P980016/S310
8/4/11
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II ICDsMedtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P980016/S311
8/4/11
Capsure, EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso IIMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P980016/S312
8/11/11
Maximo II/Secura/ VirtuosoMedtronic, Inc.
Mounds View, MN
55112
Changes to the final functional test application.
P980016/S313
8/12/11
Maximo II, Protecta, Protecta XT Secura, Virtuoso II ICDsMedtronic, Inc.
Mounds View, MN
55112
Manufacturing site change of supplier and a minor change to the wire drawing process.
P980016/S315
8/15/11
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso IIMedtronic, Inc.
Mounds View, MN
55112
Changes to a manufacturing aid.
P980016/S316
8/15/11
CapSure, EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso IIMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P980016/S317
8/19/11
Maximo II, Protecta, Protecta XT, Secura, Virtuoso II CRT’sMedtronic, Inc.
Mounds View, MN
55112
Change the Butted Contact (BTC) etch time.
P980016/S318
8/18/11
Protecta (D334DRG, D334VRG) and Protecta XT (D314DRG, D314VRG)Medtronic, Inc.
Mounds View, MN
55112
Changes to the radio frequency testing of hybrids.
P980033/S019
8/4/11
WALLSTENT™ (Venous) EndoprosthesisBoston Scientific Corporation
Maple Grove, MN
55311
Alternate vendor for the distal tip component of the delivery system for the devices.
P980035/S235
8/4/11
350 Series, Adapta, Advisa, EnRhythm, AT500, Relia, Sensia, Sigma, EnPulse, Versa IPGsMedtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P980035/S236
8/4/11
350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma VersaMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P980035/S237
8/15/11
Advisa, AT500, EnRhythmMedtronic, Inc.
Mounds View, MN
55112
Changes to a manufacturing aid.
P980035/S238
8/15/11
350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma, VersaMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P980035/S239
8/19/11
EnRhythm Implantable Pulse GeneratorMedtronic, Inc.
Mounds View, MN
55112
Change the Butted Contact (BTC) etch time.
P980043/S032
8/25/11
Hancock II Porcine BioprosthesisMedtronic, Inc.
Santa Ana, CA
92705
Addition of a glutaraldehyde supplier.
P980046/S008
8/31/11
Home Access® Hepatitis C Check SM Test SystemHome Access Health Corporation
Hoffman Estates, IL
60169
New supplier for the barrier pouch component of the device.
P980050/S065
8/4/11
Transvene CS/SVC Lead (w/polyurethane sheath)Medtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P980050/S066
8/15/11
Transvene CS/SVC Lead (w/polyurethane sheath)Medtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P990001/S092
8/4/11
Vitatron DA+
C-Series, Vitatron DA+ T-Series, Vita IPGs
Medtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P990001/S093
8/4/11
Vitatron DA+ C-Series, Vitatron DA+ T-SeriesMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P990001/S094
8/15/11
Vitatron DA+
C-Series, Vitatron DA+ T-Series
Medtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P990034/S024
8/17/11
Side Catheter Access Ports Kits/ Bulk/Refill Kits/BulkMedtronic Neuromodulation
Minneapolis, MN
55432
Update the software used at several of Medtronic’s manufacturing facilities.
P990064/S039
8/25/11
Mosaic Porcine BioprosthesisMedtronic, Inc.
Santa Ana, CA
92705
Addition of a glutaraldehyde supplier.
P000006/S025
8/18/11
Titan Inflatable Penile ProsthesisColoplast Corporation
Minneapolis, MN 55411
Addition of another supplier of tubing.
P000010/S023
8/9/11
AMPLICOR® HCV Test, Version 2Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Change to the manufacturing batch size for the Bulk Specimen Diluent, which is a component of the device.
P000012/S032
8/9/11
COBAS AMPLICOR HCV Test, v2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Change to the manufacturing batch size for the Bulk Specimen Diluent, which is a component of the device.
P010013/S039
8/18/11
NovaSure Impedance Controlled Endometrial Ablation SystemHologic, Inc.
Marlborough, MA
01752
Implementation of a new de-knitting machine.
P010015/S132
8/4/11
Consulta CRT-P, InSync III CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P010015/S134
8/4/11
Attain, Consulta CRT-P, InSync III, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P010015/S135
8/15/11
Consulta, CRT-P, InSync, InSync III, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Changes to a manufacturing aid.
P0100015/S136
8/15/11
Attain, Consulta CRT-P, InSync III, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P010015/S137
8/19/11
Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Change the Butted Contact (BTC) etch time.
P010031/S264
8/4/11
Concerto, Concerto II CRT-D,
Consulta CRT-D, InSync II Marquis, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P010031/S265
8/4/11
Concerto,
Concerto II, Consulta,
InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta II
Medtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P010031/S266
8/11/11
Concerto II/ Consulta/Maximo IIMedtronic, Inc.
Mounds View, MN
55112
Changes to the final functional test application.
P010031/S267
8/12/11
Concerto II, Consulta, Maximo II, Protecta, Protecta II CRTsMedtronic, Inc.
Mounds View, MN
55112
Manufacturing site change of a supplier and a minor change to the wire drawing process.
P010031/S269
8/15/11
Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Changes to a manufacturing aid.
P010031/S270
8/15/11
Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P010031/S271
8/19/11
Concerto II, Consulta, Maximo II, Protecta, Protecta XT CRT’sMedtronic, Inc.
Mounds View, MN
55112
Change the Butted Contact (BTC) etch time.
P010031/S272
8/18/11
Protecta (D334TRG) and Protecta XT (D314TRG)Medtronic, Inc.
Mounds View, MN
55112
Changes to the radio frequency testing of hybrids.
P010033/S018
8/23/11
QuantiFERON® - TB GoldCellestis, Inc.
Valencia, CA
91355
Change of a vendor for Glucose testing from Australia to USA.
P010054/S015
8/8/11
Elecsys Anti-HBs ImmunoassayRoche Diagnostics Corporation
Indianapolis, IN
46250
Change the in-process method to determine the particle concentration of the Elecsys coated microparticles (beads).
P020001/S008
8/4/11
STAN S31 Fetal Heart MonitorNeoventa Medical AB
Alexandria, VA 22314
Addition of an inspection test for the device.
P020025/S030
8/18/11
Maestro 3000 Cardiac Ablation SystemBoston Scientific Corporation
San Jose, CA
95134
Eight (8) test application changes to the Final Functional Test Release.
P020047/S037
8/10/11
Vision and Mini-Vision Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Change to a component in-process inspection.
P030022/S019
8/12/11
Reflection Ceramic Hip System (RCHS)Smith & Nephew, Inc.
Memphis, TN
38116
Changes to the specification governing the requalification of the ETO sterilization process for the device.
P030036/S035
8/4/11
Anchoring Sleeve Kit, SelectSecureMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P030036/S036
8/15/11
Anchoring Sleeve Kit, SelectSecureMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P030054/S194
8/12/11
Unify CRT-DSt. Jude Medical
Sylmar, CA
91342
Change in Automated Manufacturing Tests (ATE) used at the half-can level.
P030054/S195
8/15/11
Epic HF/Atlas+ HF Family of CRT-DsSt. Jude Medical
Sylmar, CA
91342
Addition of secondary suppliers for the thyristor SCR and the High Voltage/Current diode components.
P040016/S075
8/4/11
Liberté Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the inflation manifold component inspection process.
P040024/S054
8/18/11
Restylane Injectable GelMedicis Pharmaceutical Corporation
Scottsdale, AZ
85256
New fill volume for the device and a new needle size to be used with the new fill volume.
P050007/S029
8/10/11
Vascular Closure SystemsAbbott Vascular, Inc.
Redwood City, CA
94063
Change in BET location and technique.
P050012/S038
8/12/11
Dexcom SEVEN® and SEVEN® PLUS Continuous Glucose Monitoring SystemsDexcom, Inc.
San Diego, CA
92121
Removal of redundant deburring steps from the cleaning processes of the needle and cannula components of the SEVEN and SEVEN PLUS Continuous Glucose Monitoring Systems.
P060008/S074
8/4/11
TAXUS Liberté Long Paclitaxel- Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the inflation manifold component inspection process.
P060039/S029
8/4/11
Attain StarFixMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P060039/S030
8/15/11
Attain StarFixMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P070001/S011
8/18/11
ProDisc-C Total Disc ReplacementSynthes Spine
West Chester, PA
19380
Change to the location of the tray manufacturing and raw material supplier.
P070015/S076
8/10/11
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System (EECSS)Abbott Vascular
Temecula, CA
92591
Change to a component in-process inspection.
P070015/S078
8/25/11
XIENCE nano and PROMUS Everolimus Eluting Coronary Stent SystemsAbbott Vascular
Temecula, CA
92591
Changes to include: 1) removal of initial clean and plasma treatment; 2) removal of drug final weigh; 3) modified clean room gowning; and 3) modifications to the spray coating process.
P080006/S033
8/4/11
Attain Ability, Attain Ability Plus, Attain Ability StraightMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P080006/S034
8/15/11
Attain Ability, Attain Ability Plus, Attain Ability StraightMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P080014/S009
8/2/11
Cervista® HPV HRHologic, Inc.
Marlborough, MA
01752
Change in the statistical method employed during incoming material inspection of the HPV Controls of the Cervista® HPV HR and reagents in the Genfind® DNA Extraction Kit.
P080015/S005
8/2/11
Cervista® HPV 16/18Hologic, Inc.
Marlborough, MA
01752
Change in the statistical method employed during incoming material inspection of the HPV Controls of the Cervista® HPV 16/18 and reagents in the Genfind® DNA Extraction Kit.
P080025/S012
8/5/11
Leads 3889/3093, Lead Extension 3095Medtronic, Inc.
Minneapolis, MN
55432
Changes to the blister sealing operation and the inspection specifications for that operation.
P080025/S014
8/17/11
Interstim Family of Implantable NeurostimulatorsMedtronic, Inc.
Minneapolis, MN
55432
Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P080025/S015
8/17/11
InterStim Family of INSMedtronic Neuromodulation
Minneapolis, MN
55432
Update the software used at several of Medtronic’s manufacturing facilities.
P080025/S017
8/24/11
InterStim II NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN
55432
Changes to manufacturing equipment and in process inspectional methods.
P080025/S019
8/30/11
InterStim II NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN
55432
Addition of a new manufacturing mold and a new component supplier.
P090013/S031
8/4/11
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P090013/S032
8/4/11
CapSure Fix Lead, Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Software upgrade for the manufacturing execution system.
P090013/S033
8/15/11
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Changes to a manufacturing aid.
P090013/S034
8/15/11
CapSure Fix Lead, Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Modification to equipment calibration control.
P090013/S035
8/19/11
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Change the Butted Contact (BTC) etch time.
P090022/S006
8/25/11
Softec HD, Softec I, and Softec HD PS Intraocular LensesLenstec, Inc.
Saint Petersburg, FL
33716
Use of an alternative supplier of the silicone vial stopper.
P100013/S001
8/25/11
EXOSEAL™ Vascular Closure DeviceCordis Corporation
Bridgewater, NJ
08807
Change in the processing of a component of the device.
P100014/S002
8/10/11
Solesta Injectable GelSchiff & Company
West Caldwell, NJ 07006
Relocation of the Quality Control Laboratory to a new location within Q-Med AB’s existing facility.
P100021/S009
8/10/11
Endurant Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Several manufacturing changes at the component supplier.
P100023/S009
8/4/11
ION Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Manufacturing process step to enhance scanning and data retrieval function.
P100023/S011
8/4/11
ION Paclitaxel-Eluting Coronary Stent System MonorailBoston Scientific Corporation
Maple Grove, MN
55311
Change to the inflation manifold component inspection process.
P100023/S012
8/4/11
ION Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Optimization of in-process manufacturing inspections.
P100023/S014
8/11/11
ION (Taxus Element) Paclitaxel-Eluting StentBoston Scientific Ireland, Inc.
Maple Grove, MN
55311
Modification of the sleeve cutting guide fixture.

Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 70

Summary of PMA Originals Under Review
Total Under Review: 92
Total Active: 47
Total On Hold: 45
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 619
Total Active: 433
Total On Hold:186
Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received
Originals: 2
Supplements: 69

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 157.2
FDA Time: 105.4 Days MFR Time: 51.8 Days