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U.S. Department of Health and Human Services

Medical Devices

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December 2012 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 APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P110014
12/27/12		 MarginProbe System Dune Medical Devices, Incorporated
Philadelphia, PA
19103		 Approval for the MarginProbe System. This device is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P840001/S223
12/3/12
135-Day		 Spinal Cord Stimulation-Implantable Neurostimulators
RestorePrime®;
Spinal Cord Stimulation-Implantable Neurostimulators
PrimeAdvanced®;
Spinal Cord Stimulation-Implantable Neurostimulators; and Itrel® 4		 Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval for addition of the in-process inspection for the cathod mix used in battery models.
P840001/S230
12/17/12
Real-Time		 Itrel 3, Itrel 4, Synergy, Synergy Versitrel, Restore, Restore Prime, Restore Advanced, Prime Advanced and Restore Ultra Spinal Cord Stimulation Systems Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval for minor changes to Model 8840 N'Vision Programmer Software for End of Service and Low/ Empty Reservoir Alarms.
P860004/S177
12/17/12
Real-Time		 N'Vision Software Application Card used with the N'Vision Programmer Medtronic Incorporated
Minneapolis, MN
55432		 Approval for Minor Changes to Model 8840 N'Vision Programmer
Software for End of Service and Low/Empty Reservoir Alarms and is indicated for use with SynchroMed EL and SynchroMed II Pumps.
P860004/S179
12/20/12
Special		 SynchroMed El and SynchroMed II Infusion System Medtronic, Inc.
Minneapolis, MN
55432		 Approval for updated warning and precautions and procedures related to subcutaneous overdose.
P870072/S050
12/27/12
180-Day		 Thoratec® Ventricular Assist Device (VAD) Thoratec Corporation
Pleasanton, CA
94588		 Approval for minor design changes to the TLC-II Portable VAD battery pack.
P880086/S202
12/4/12
180-Day		 Identity, Integrity Microny, Victory, Zephyr and Accent Pacemakers St. Jude Medical
Sunnyvale, CA
94086		 Approval for a material change from medical grade polysulfone to biograde polysulfone.
P890003/S263
12/11/12
Real-Time		 Analyzer Medtronic, Inc.
Mounds View, MN
55112		 Approval of an update to the 2290 Analyzer Software.
P910023/S263
12/4/12
180-Day		 Epic, Atlas,
Current and
Fortify ICD's		 St. Jude Medical
Sunnyvale, CA
94086		 Approval for a material change from medical grade polysulfone to biograde polysulfone.
P910023/S307
12/19/12
180-Day		 EX2000 Software Version 6.1M for marlin@home without the Cellular Adapter and Software version 6.0 for Merlin.net System St. Jude Medical
Sunnyvale, CA
94086		 Approval for the EX2000 Software Version 6.1M for marlin@home without the Cellular Adapter and Software version 6.0 for Merlin.net System.
P910073/S102
12/21/12
180-Day		 ENDOTAK RELIANCE 4-SITE  Lead and Accessory Models Guidant Corporation
St. Paul, MN
55112		 Approval for the post-approval study protocol.
P910073/S107
12/20/12
180-Day		 ENDOTAK RELIANCE 4-SITE Passive Fixation Leads Boston Scientific CRV
St. Paul, MN
55112		 Approval for drug material and supplier changes as well as distal tip design changes.
P920015/S098
12/19/12
Real-Time		 Sprint Quattro and Subcutaneous Lead Medtronic, Inc.
Mounds View, MN
55112		 Approval for change in silicone tubing material used in the manufacture of various cardiac leads as a result of discontinuation of the current material by an outside supplier.
P920015/S099
12/19/12
Real-Time		 Sprint Quattro, Lead Medtronic, Inc.
Mounds View, MN
55112		 Approval for a mechanical design change to the Sprint Quattro Model 6935M and Model 6947M lead analyzer cable interface accessory.
P950029/S072
12/11/12
Real-Time		 Reply SR/DR and Esprit SR/DR Sorin CRM USA, Inc.
Plymouth, MN 55441 		Approval for a change to the quartz crystal.
P950037/S107
12/3/12
135-Day		 Philos DR/DR-B/SR/SR-B/DR-T, Philos II DR/DR-T/SR, Cylos DR/DRT/R,
Evia DR/DR-T/SR/SR-T, Entovis DR/DR-T/SR/SR-T, Estella
DR/DR-T/SR/SR-T, Ecuro DR/DR-T/SR/SR-T, Effecta D/DR/S/SR
Pulse Generators.		 Biotronik, Inc.
Lake Oswego, OR
97035		 Approval for an update to parameters used in laser welding processes.
P960009/S152
12/3/12
135-Day		 DBS Implantable Neurostimulators Activa®PC and
DBS Implantable Neurostimulators Activa®SC		 Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval for addition of the in-process inspection for the cathod mix used in battery models.
P960009/S160
12/17/12
Real-Time		 Activa PC, Activa SC, Activa RC, Kinetra and Soletra Deep Brain Stimulation Systems Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval for minor changes to Model 8840 N'Vision Programmer Software for End of Service and Low/ Empty Reservoir Alarms.
P960040/S262
12/21/12
180-Day		 TELIGEN 4-SITE Header ICD Models Guidant Corporation
St. Paul, MN
55112		 Approval for the post-approval study protocol.
P970004/S138
12/3/12
135-Day		 Sacral Nerve Stimulation- Urinary-Implantable Neurostimulators
InterStim II		 Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval for addition of the in-process inspection for the cathod mix used in battery models.
P970029/S022
12/18/12
180-Day		 PEARL 8.0 Handpiece Cardiogenesis Corporation
Kennesaw, GA
30144		 Approval for the post-approval study protocol.
P970053/S012
12/12/12
Real-Time		 Nidek Excimer Laser System Nidek, Inc.
Gamagori, Aichi
Japan 		Approval for replacement of the laser diode for the aiming beam, the
corresponding modification of the aiming beam optical system, and associated labeling changes.
P980016/S388
12/12/12
Real-Time		 Concerto II/ Consulta/Maximo II/Protecta/Secura/ Virtuoso Family of CRT-Ds and ICDs Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to the L303 and L310 Integrated Circuit.
P980024/S007
12/20/12
135-Day		 PathVysion HER-2 DNA Probe Kit Abbott Molecular, Inc.
Des Plaines, IL
60018		 Approval for the manufacturing change to components of the ProbeChek HER-2/neu Cutoff Control slides used in the PathVysion HER-2 DNA Probe Kit.  The change included creation of a new Master Cell Bank and a new Working Cell Bank from seed stock of Hs578T cells, used in the manufacture of the ProbeChek HER-2/neu Cutoff Control slides.
P980035/S296
12/11/12
Real-Time		 Adapta, Adapta L, Adapta S, Sensia L, Sensia Versa and Relia IPG Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to a capacitor.
P980035/S298
12/12/12
Real-Time		 Advisa DR IPG Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to the L303 and L310 Integrated Circuit.
P980049/S061
12/21/12
180-Day		 Ovatio DR and VR Implantable Cardioverter Defibrillators Sorin CRM, USA
Plymouth, MN
55441		 Approval for updating the labeling of the devices based on the post-approval study results.
P990012/S013
12/20/12
135-Day		 Elecsys® HBsAg Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly
constructed manufacturing space.
P990034/S029
12/20/12
Special		 IsoMed Infusion Pump Medtronic, Inc.
Minneapolis, MN
55432		 Approval for updated warning and precautions and procedures related to subcutaneous overdose.
P990056/S016
12/18/12
135-Day		 Elecsys Total PSA Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval to transfer a portion of the manufacturing operations, specifically compounding of bulk reagents, to newly constructed buildings 662 and 663 within the Roche Penzberg, Germany facility.
P000027/S014
12/18/12
135-Day		 Elecsys Free PSA Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval to transfer a portion of the manufacturing operations, specifically compounding of bulk reagents, to newly constructed buildings 662 and 663 within the Roche Penzberg, Germany facility.
P000039/S047
12/19/12
Special		 AMPLATZER® Septal Occluder AGA Medical Corporation
Plymouth, MN
55442		 Approval for labeling changes regarding device erosion.
P010012/S292
12/21/12		 COGNIS 4-SITE Header CRT-D Models Guidant Corporation
St. Paul, MN
55112		 Approval for the post-approval study protocol.
P010012/S315
12/20/12
Real-Time		 ACUITY Spiral and EASYTRAK 3 IS-1 Boston Scientific Corporation
St. Paul, MN
55112		 Approval for an alternate primer material.
P010015/S182
12/12/12
Real-Time		 Consulta/Syncra Family of CRT-Ps Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to the L303 and L310 Integrated Circuit.
P010030/S037
12/20/12
Real-Time		 Lifevest Wearable Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA
15238		 Approval for a minor change in software/firmware for your Lifevest Wearable Defibrillator (WCD 4000) device to support two FDA approved accelerometers. The software/firmware change enables the subject device to detect between the accelerometers, to calibrate the accelerometer and adjust for accelerometer output polarity.
P010030/S039
12/20/12
Real-Time		 LifeVest Wearable Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA
15238		 Approval for:
1) Design modifications to the Monitor Enclosure;
2) Addition of EP11HT Gray epoxy to the high voltage capacitor solder joints; and
3) Addition of Loctite 3536 epoxy underfill to the Ball Grid Array components of the printed circuit assemblies
P010031/S340
12/12/12
Real-Time		 Concerto II/ Consulta/Maximo II/Protecta/Secura/ Virtuoso Family of CRT-Ds and ICDs Medtronic, Inc.
Mounds View, MN
55112		 Approval for an update to the L303 and L310 Integrated Circuit.
P010047/S024
12/7/12
180-Day		 ProGel Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
92618		 Approval of the post-approval study protocol.
P010054/S018
12/20/12
135-Day		 Elecsys® Anti-HBs Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly constructed manufacturing space.
P020014/S039
12/20/12
180-Day		 Essure Post-Nova 
-Sure Radiofrequency Endometrial Ablation		 Conceptus, Inc.
Mountain View, CA
94041		 Approval of the post-approval study protocol.
P020018/S044
12/12/12
180-Day		 The Zenith Fenestrated AAA Endovascular Graft Cook Incorporated
Bloomington, IN
47402		 Approval of the post-approval study protocol.
P030017/S134
12/21/12
180-Day		 Precision Spectra™ System Boston Scientific Corporation
Valencia, CA
91355		 Approval for the Precision Spectra™ System which includes the following components:
1) Model SC-1132 Precision Spectra™ Implantable Pulse Generator (lPG);
2) Model SC-4401 Precision Spectra™ lPG Port Plug;
3) Model SC-5132 Precision Spectra™ External Trial Stimulator;
4) Model SC-6360-32 Precision Spectra™ Patient Trial Belt; 4) Model SC-6500-32 Patient Trial Kit; 5) Model SC-5232 Precision Spectra™ Remote Control; 6) Model SC-5532-1 Precision Spectra™ Remote Control Kit;
7) Model NM-6310 and NM-6210 USB Power Supply; and
8) Model NM-6210 Remote Control Holster.  The device, as modified, will be marketed under the trade name Precision Spectra™ System and is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following:  failed back surgery syndrome, intractable low back pain and leg pain.
P030035/S082
12/4/12
180-Day		 Frontier II Pacemaker and Anthem CRT-P St. Jude Medical
Sunnyvale, CA
94086		 Approval for a material change from medical grade polysulfone to biograde polysulfone.
P030036/S051
12/19/12
Real-Time		 SelectSecure Medtronic, Inc.
Mounds View, MN
55112		 Approval for change in silicone tubing material used in the manufacture of various cardiac leads as a result of discontinuation of the current material by an outside supplier.
P030054/S188
12/4/12
180-Day		 Promote ICD, Promote CRT-D, Unify ICD and Unify CRT-D St. Jude Medical
Sunnyvale, CA
94086		 Approval for a material change from medical grade polysulfone to biograde polysulfone.
P030054/S237
12/19/12
180-Day		 EX2000 Software version 6.1M for marlin@home without the Cellular Adapter St. Jude Medical
Sunnyvale, CA
94086		 Approval for the EX2000 Software version 6.1M for marlin@home without the Cellular Adapter.
P040002/S040
12/28/12
Real-Time		 Endologix AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618		 Approval for the addition of bifurcated stent graft models for the approved AFX Endovascular AAA System product family.  The new models contain shorter and longer bifurcated bodies that will have the same diameter as those currently approved; and to add 20mm diameter limbs using the same stent cage.
P040005/S007
12/5/12
180-Day		 HER2 IQFISH pharmDx™ Dako Denmark A/S
Glostrup, Denmark
DK-2600		 Approval for modifications to the formulation of the HER2 FISH pharmDx™
Kit. The device, as modified, will be marketed under the trade name HER2 IQFISH pharmDx™.
P040012/S050
12/19/12
Real-Time		 RX Acculink® Carotid Stent System Abbott Vascular, Inc.
Santa Clara, CA
95054		 Approval for modification to the RX Acculink® Carotid Stent System's bonding of the Inner Member, Guidewire Lumen and Notched Hypotube.
P040050/S010
12/28/12
180-Day		 Macroplastique Implants Uroplasty, Inc.
Minnesota, MN
55343		 Approval to qualify an alternative silicone elastomer material for the Macroplastique syringe stopper, as well as an alternative supplier of the syringe stopper (NuSil Technology, LLC at Carpinteria, CA.)  There is no change to the indications for use or labeling of the Macroplastique device.
P050012/S046
12/14/12
135-Day		 Dexcom Seven Plus Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA
92121		 Approval to add an additional sealer in the pouch sealing process used to seal the Dexcom SEVEN Sensors into Tyvek porous pouches.
P050046/S019
12/20/12
Real-Time		 ACUITY Steerable Lead Family Boston Scientific Corporation
St. Paul, MN
55112		 Approval for an alternate primer material.
P070008/S032
12/3/12
135-Day		 Stratos LV/LV-T CRT-Ps Biotronik, Inc.
Lake Oswego, OR
97035		 Approval for an update to parameters used in laser welding processes.
P080011/S015
12/18/12
180-Day		 Breathables XW Sphere (comfilcon A) Soft (hydrophilic) Contact Lens and
Breathables XW Toric (comfilcon A) Soft (hydrophilic) Contact Lens 		CooperVision, Inc.
Pleasanton, CA
94588		 Approval for the addition of a new private label brand name Breathables XW.
P080025/S035
12/3/12
135-Day		 Sacral Nerve Stimulation-Bowel-Implantable Neurostimulators
InterStim II		 Medtronic Neuromodulation
Minneapolis, MN
55432		 Approval for addition of the in-process inspection for the cathod mix used in battery models.
P080027/S007
12/17/12
Special		 OraQuick® HCV Rapid Antibody Test OraSure Technologies, Inc.
Bethlehem, PA
18015		 Approval for a new quality control test method for evaluation of a raw material used in the manufacturing of the device.
P090002/S007
12/21/12
Special		 Pinnacle® CoMplete® Acetabular Hip System DePuy Orthopaedics, Incorporated
Warsaw, IN
46581		 Approval for changes to the product labeling/ information for use for the device.
P090007/S007
12/20/12
135-Day		 Elecsys® Anti-HCV on cobas e 411 Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly
constructed manufacturing space.
P090008/S008
12/20/12
135-Day		 Elecsys® Anti-HCV on cobas e 601 Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly
constructed manufacturing space.
P090009/S007
12/20/12
135-Day		 Elecsys® Anti-HCV on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly
constructed manufacturing space.
P090016/S003
12/7/12
180-Day		 Belotero Balance Merz Aesthetics, Inc.
Franksville, WI
53126		 Approval of the post-approval study protocol.
P100021/S018
12/26/12
180-Day		 Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403		 Approval for a manufacturing site located at Medtronic México EG in Empalme Sonora, Mexico, for stent graft sewing.
P100031/S005
12/20/12
135-Day		 Elecsys® Anti-HBc on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly
constructed manufacturing space.
P100032/S005
12/20/12
135-Day		 Elecsys® Anti-HBc on Elecsys 2010 Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly
constructed manufacturing space.
P100034/S002
12/3/12
Real-Time		 NovoTTF-100A System NovoCure, Ltd.
Rye Beach, NH
03871		 Approval for modification to the field generator component of the
NovoTTF-l00A System to replace P/N: DAC7614E with P/N: 2IC-103572, and corresponding
changes to the associated resistors and capacitors to limit the part voltage range and eliminate an
observed current spike.   Corresponding software changes were also made to reflect these
modifications.
P110010/S026
12/21/12
180-Day		 PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Approval for a change to the body length of the delivery system balloon.
P110013/S002
12/21/12		 Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular, Inc.
Santa Rosa, CA
95403		 Approval for the introduction of a stent alignment manufacturing process and a marker band spacing specification change.
P110019/S025
12/21/12		 XIENCE Xpedition™, XIENCE Xpedition™ Small Vessel and XIENCE Xpedition™ Long Lesion Everolimus Eluting Coronary Stent System Abbott Vascular, Inc.
Santa Clara, CA
95054		 Approval for a newly designed delivery catheter. The device, as modified, will be marketed under the trade name XIENCE Xpedition™, XIENCE Xpedition™ Small Vessel (SV) and XIENCE Xpedition™ Long Lesion (LL) Everolimus Eluting Coronary Stent System and is indicated for improving coronary luminal diameter in subjects with symptomatic heart disease due to de novo native coronary artery lesions (length ≤  32mm) with reference vessel diameter of  ≥ 2.25mm to ≤ 4.25mm.
P110022/S002
12/20/12
135-Day		 Elecsys® Anti-HBc IgM on cobas e 601 Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly constructed manufacturing space.
P110025/S002
12/20/12
135-Day		 Elecsys® Anti- HBc IgM on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly constructed manufacturing space.
P110031/S002
12/20/12
135-Day		 Elecsys® Anti-HBc IgM on cobas e 411 Roche Diagnostics Corporation
Indianapolis, IN
46250		 Approval for a  transfer of a portion of the manufacturing operations for the bulk solutions of reagents R1 and R2, as well as bulk solutions of pretreatment reagents to newly constructed manufacturing space.
P110038/S001
12/18/12
180-Day		 Relay Thoracic Stent Graft with Plus Delivery System Bolton Medical, Inc.
Sunrise, FL
33325		 Approval for the post-approval study protocol.
P120006/S001
12/11/12
Real-Time		 Ovation Prime Abdominal Stent Graft System TriVascular, Inc.
Santa Rosa, CA
95403		 Approval for modifications to the endovascular system, mainly the delivery system, to improve the ease-of-use during deployment.  The device, as modified, will be marketed under the trade name Ovation Prime Abdominal stent Graft System and is indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including:
1) Adequate iliac/femoral access compatible with vascular access techniques, devices and/or accessories;
2) Non-aneurysmal proximal aortic neck:  a) with a length of at least 7 mm proximal to the aneurysm, b) with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and c) with an aortic angle of ≤ 60 degree if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm.
3) Adequate distal iliac landing zone:  a) with a length of at least 10 mm, and
b) with an inner wall diameter of no less then 8 mm and no greater than 20 mm.

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

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N18033/S067
12/11/12		 VISTAKON (etafilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256		 Modifications to an in-process test method.
P790002/S029
12/31/12		 Bio Osteogen System 204, EBI Bone Healing System and Biomet BHS-Mini EBI, LLC
Parsippany, NJ
07054		 New crimping equipment and crimp connector for the bone healing treatment coils.
P790007/S033
12/19/12		 Hancock Modified Orifice Valved Conduit Medtronic Heart Valves
Santa Ana, CA
92705		 Modification of the dimensions of an existing clean room
P820003/S118
12/4/12		 Patient Cables Medtronic, Inc.
Mounds View, MN
55112		 Manufacturing changes to the D01 connector and solder and flux.
P820003/S119
12/20/12		 Adaptor Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P820021/S035
12/18/12		 Vifilcon A Contact Lenses for Extended Wear Ciba Vision Corporation
Duluth, GA
30097		 Changes in two test methods.
P820060/S031
12/11/12		 AxSym AFP Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied Brij L23 Solution.
P830026/S081
12/5/12		 Cosmos Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P830060/S074
12/5/12		 Ventak ICD Family Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P830061/S082
12/20/12		 CapSure, Vitatron Crystalline, and Vitatron Excellence PS+ Leads Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P830061/S083
12/26/12		 CapSure Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead Medtronic, Inc.
Mounds View, MN
55112		 Additional supplier for extruded tubing.
P840064/S052
12/12/12		 VISCOAT and DUOVISC Ophthalmic Viscosurgical Devices Alcon Laboratories, Incorporated
Fort Worth, TX
76134		 Addition of an alternate syringe supplier.
P840068/S052
12/5/12		 Delta/Vista Families Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P850079/S062
12/4/12		 Methafilcon A and Methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588		 Increase the capacity of dry lens manufacturing.
P850089/S091
12/20/12		 CapSure SP Novus, CapSure SP Z, CapSure Z Novus, and Impulse II
Leads		 Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P860004/S178
12/6/12		 SynchroMed II Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432		 Manufacturing change to automate reading of identifiers for the SynchroMed II Infusion Pump, Model 8637. 
P860057/S096
12/10/12		 Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of a Quality Management System software.
P860057/S097
12/11/12		 Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of jar torque machines.
P860057/S099
12/28/12		 Carpentier-Edwards Perimount  Pericardial Aortic Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614		 Addition of two new flow testers.
P870056/S053
12/10/12		 Carpentier-Edwards Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of a Quality Management System software.
P870056/S054
12/11/12		 Carpentier-Edwards Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of jar torque machines.
P870077/S048
12/10/12		 Carpentier-Edwards Duraflex Lowe Pressure Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of a Quality Management System software.
P870077/S049
12/11/12		 Carpentier-Edwards Duraflex Lowe Pressure Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of jar torque machines.
P870078/S017
12/19/12		 Hancock Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA
92705		 Modification of the dimensions of an existing clean room
P890003/S266
12/20/12		 CapSure Lead, Prodigy IPG, and Service Kit-Pacemaker Repair Kit Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P890061/S022
12/5/12		 Ventak P ICD Families Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P900056/S117
12/28/12		 Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN
55311		 Transfer of the endotoxin (LAL) testing to a new location.
P900056/S118
12/11/12		 Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN
55311		 Use of an electronic records system.
P900061/S117
12/12/12		 Patient Magnet Medtronic, Inc.
Mounds View, MN
55112		 Transfer of a supplier manufacturing operation to a new location.
P900061/S118
12/20/12		 ACE Header, Defibrillation Support Device, End Cap, Epicardial Patch Lead, Sizing Sleeve and Upsizing Sleeve Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P910001/S062
12/26/12		 ELCA Coronary Atherectomy Catheter Spectranetics Corporation
Colorado Springs, CO
80921		 Addition of a new computer numeric control (CNC) machining tool.
P910007/S036
12/11/12		 Architect Total PSA and AxSYM Total PSA Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied Brij L23 Solution.
P910007/S037
12/7/12		 ARCHITECT Total PSA Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P910007/S038
12/7/12		 ARCHITECT Total PSA Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P910023/S310
12/17/12		 Current Family of ICDs St. Jude Medical
Sunnyvale, CA
94086		 Modifications to automated manufacturing tests.
P910073/S112
12/5/12		 Endotak and Reliance Lead Families Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P910073/S113
12/12/12		 RELIANCE DF4 Leads Boston Scientific Corporation
St. Paul, MN
55112		 Upgrade the Final Test Station (FTS) equipment.
P910073/S114
12/18/12		 RELIANCE IS-1 and IS-4 Active and Passive Defibrillation Leads Boston Scientific Corporation
St. Paul, MN
55112		 New laser welding equipment used for the manufacturing of defibrillation leads.
P910077/S129
12/5/12		 Ventak PRx and Ventak Mini ICD Families Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P920015/S100
12/20/12		 "Y" Adaptor/ Extender Kit, DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug, Lead Adaptor, Sprint Quattro Lead, Subcutaneous Lead,
Transvene SVC Lead, and Tunneling Tool		 Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P920015/S101
12/26/12		 Sprint Quattro Lead Medtronic, Inc.
Mounds View, MN
55112		 Additional supplier for extruded tubing.
P930029/S037
12/20/12		 RF Conductr 5 mm (7fr, 8fr Tip), RF Conductr 4 mm (7fr), RF Contactr 5
mm (7fr, 8fr Tip), RF Contactr 4 mm (7fr), RF Enhancer II 4 mm (7fr), RF Marinr 4 mm (7Fr), RF Marinr 4 mm (5Fr) and RF Marinr Unipolar
4 mm (7fr) 		Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P930029/S038
12/21/12		 RF Enhancer II Ablation Catheter AF Solutions
Mounds View, MN
55112		 Transfer incoming inspection activities.
P930031/S038
12/18/12		 WALLSTENT (TIPS) Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311		 Addition of alternate supplier for polymer films used in packaging.
P930031/S039
12/11/12		 WALLSTENT TIPS Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311		 Use of an electronic records system.
P930035/S024
12/5/12		 Ventak P2 ICD Families Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P930039/S078
12/20/12		 CapSureFix, CapSureFix Novus, SureFix, Torque Clip Device-Accessory for 5076, and Vitatron Crystalline Leads Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P930039/S079
12/26/12		 CapSureFix Novus Lead, Vitatron Crystalline Lead Medtronic, Inc.
Mounds View, MN
55112		 Additional supplier for extruded tubing.
P940019/S033
12/18/12		 WALLSTENT (Iliac) Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311		 Addition of alternate supplier for polymer films used in packaging.
P940019/S034
12/11/12		 WALLSTENT Iliac Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311		 Use of an electronic records system.
P940031/S074
12/5/12		 Vigor DR/SR, Discovery, Meridian Families Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P940034/S019
12/5/12		 Amplified MTD® (Mycobacterium Tuberculosis Direct) Test Gen-Probe Incorporated
San Diego, CA
92121		 Change in the amplification positive control used for Quality Control testing.
P950001/S025
12/5/12		 Selute Lead Family Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P950020/S057
12/11/12		 Coronary Flextome Cutting Balloon Boston Scientific Corporation
Maple Grove MN
55311		 Removal of a redundant step in the catheter assembly.
P950020/S058
12/13/12		 Coronary Flextome Cutting Balloon Boston Scientific Corporation
Maple Grove MN
55311		 Addition of alternate manufacturing equipment to test for balloon leaks in the devices
P950020/S059
12/11/12		 Flextome Cutting Balloon Dilation Device Boston Scientific Corporation
Maple Grove MN
55311		 Use of an electronic records system.
P950024//S046
12/20/12		 CapSure Epidardial Pacing Lead Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P950037/S114
12/19/12		 Evia DR/SR, Entovis DR/SR, Estella DR/SR, Effecta D/DR/SR,
Ecuro DR/SR Implantable Pulse Generators		 Biotronik, Inc.
Oswego, OR
97035		 Alternate supplier for the snap-can housing.
P960004/S058
12/5/12		 Thinline/Fineline Family of Endocardial Pacing Leads Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P960006/S037
12/5/12		 Sweet Tip Rx, Sweet Picotip Rx, and Flextend Lead
Families		 Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P960040/S261
12/5/12		 Ventak Av, Ventak Prizm DR/VR, Vitality, Confient,
and Teligen, Punctua, Energen, and Incepta lCD Families 		Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P960040/S282
12/11/12		 TELIGEN, INCEPTA,  ENERGEN AND PUNCTUA ICDs Boston Scientific Corporation
St. Paul, MN
55112		 Add a new off-the-shelf laser welder for use in the battery manufacturing.
P960042/S045
12/26/12		 Spectranetics Laser Sheaths (SLS) Spectranetics Corporation
Colorado Springs, CO
80921		 Addition of a new computer numeric control (CNC) machining tool.
D970003/S145
12/5/12		 Pulsar, Pulsar Max, Insignia, Altrua Families Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P970008/S062
12/20/12		 Targis Targeted Transurethral Thermoablation System (Targis System) Urologix, Inc.
Minneapolis, MN
55447		 Implementation of alternative pouch sealing equipment for packaging a component of the device.
P970027/S018
12/5/12		 AxSYM Anti-HCV Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P970031/S037
12/19/12		 Freestyle Aortic Root Bioprosthesis Medtronic Heart Valves
Santa Ana, CA
92705		 Modification of the dimensions of an existing clean room
P980003/S037
12/17/12		 Chilli II Cool Ablation Catheter Boston Scientific
San Jose, CA
95134		 Updates to the in-process inspection.
P980007/S027
12/11/12		 Architect Free PSA and AxSYM Free PSA Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied Brij L23 Solution.
P980007/S028
12/7/12		 ARCHITECT Free PSA Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P980007/S29
12/7/12		 ARCHITECT Free PSA Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P980016/S390
12/12/12		 Patient Magnet Medtronic, Inc.
Mounds View, MN
55112		 Transfer of a supplier manufacturing operation to a new location.
P980016/S391
12/11/12		 Maximo II DF4 CRT-D, Maximo II DF4, Maximo II, Protecta, Protecta DF4, Protecta XT DF4, Protecta XT, Secura DF4, Secura, Virtuoso II DR/VR ICDs
 
 
 		 Medtronic, Inc.
Mounds View, MN
55112		 Add High Temperature Monitor to High Power Lean Line.
P980016/S392
12/20/12		 Instrinsic, Marquis VR, Marquis DR, Maximo II, Maximo DR, Maximo VR, Protecta, Protecta XT, Secura, Virtuoso, and Virtuoso II DR/VR
ICDs		 Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P980024/S009
12/26/12		 PathVysion HER-2 DNA Probe Kit Abbott Molecular, Inc.
Des Plaines, IL
60018		 Qualify the GENEPREP instrument, qualify the overhead mixing system and validate the mixing process in the manufacture of the hybridization buffer, and transfer an existing in-process testing of labeled DNA.
P980031/S011
12/19/12		 INTACS Corneal Implants Addition Technology
Des Plaines, IL
60016		 Outsourcing of the INTACS segment thickness and packaging component inspection activities.
P980033/S027
12/18/12		 WALLSTENT (Venous) Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311		 Addition of alternate supplier for polymer films used in packaging.
P980033/S028
12/11/12		 WALLSTENT Venous Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311		 Use of an electronic records system.
P980035/S299
12/4/12		 Advisa DR IPG Medtronic, Inc.
Mounds View, MN
55112		 Update to the battery burn-in process and inspection methods.
P980035/S300
12/12/12		 Advisa DR IPG Medtronic, Inc.
Mounds View, MN
55112		 Updates to the final test application.
P980035/S301
12/20/12		 Adapta, Sensia, Versa, Advisa and Relia IPGs Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P980043/S036
12/19/12		 Hancock II Bioprosthetic Heart Valve Medtronic Heart Valves
Santa Ana, CA
92705		 Modification of the dimensions of an existing clean room.
P980043/S037
12/28/12		 Hancock II Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705		 Change to the machining process for stents.
P980050/S079
12/20/12		 Transvene Lead Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P990001/S109
12/20/12		 Vitatron C20 SR, Vitatron C60 DR, Vitatron T20 SR, and Vitatron T60
DR IPGs		 Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P990012/S019
12/20/12		 Elecsys® HBsAg Immunoassay, Elecsys® HBsAg Confirmatory Test, and Elecsys®
HBsAg Preci-Control 		Roche Diagnostics Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P990056/S019
12/26/12		 Elecsys® Total PSA CalSet Roche Diagnostic Corporation
Indianapolis, IN
46250		 Transfer from packaging line 20 in Building 398, to packaging line 19 in Building 493 within the Mannheim, Germany site and to change the box and spacer element size, main and side label size, and label layout.
P990064/S044
12/19/12		 Mosaic Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA
92705		 Modification of the dimensions of an existing clean room.
P990064/S045
12/28/12		 Mosaic Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705		 Change to the machining process for stents.
P000007/S035
12/10/12		 Edwards Prima Plus Stentless Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of a Quality Management System software.
P000007/S036
12/11/12		 Edwards Prima Plus Stentless Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of jar torque machines.
P000025/S066
12/4/12		 MED-EL COMBI 40+ Cochlear Implant System MED-EL Elektro-Medizinische Geräte GmbH
Innsbruck-Fürstenweg 77a, Austria
A-6020		 Addition of three cleanroom ECA (Enviromentally Controlled Area) modules.
P000029/S073
12/19/12		 Deflux Injectable Gel Salix Pharmaceuticals, Inc.
Raleigh, NC
27615		 Change the method of verification of printed information on the product labels.
P000037/S031
12/1/12		 On-X Prosthetic Heart Valve On-X Technologies, Inc.
Austin, TX
78752		 Move the machining process for specified sizes of valve housing substrates in-house.
P010012/S314
12/5/12		 Contrak CD, Livian, Cognis, Energen, Punctua, and Incepta CRT-Ds and Acuity Spiral and EasyTrak
Heart Failure Lead Systems		 Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P010012/S316
12/11/12		 COGNIS, INCEPTA, ENERGEN AND PUNCTUA
CRT-Ds		 Boston Scientific Corporation
St. Paul, MN
55112		 Add a new off-the-shelf laser welder for use in the battery manufacturing.
P010014/S040
12/21/12		 Oxford® Partial Knee System Biomet, Inc.
Warsaw, IN
46581		 Manufacturing changes related to the knee system.
P010015/S183
12/12/12		 Consulta and Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112		 Updates to the final test application.
P010015/S184
12/20/12		 Attain Bipolar OTW Lead, Consulta CRT-P, Left Venticular Pacing Lead and Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P010015/S185
12/26/12		 Attain Bipolar OTW Lead Medtronic, Inc.
Mounds View, MN
55112		 Additional supplier for extruded tubing.
P010031/S341
12/11/12		 Concerto II CRT-D, Consulta DF4, Consulta ICDs, Maximo II, Maximo DF4, Protecta, Protecta DF4, Protecta XT, Protecta XT DF4 CRT-Ds Medtronic, Inc.
Mounds View, MN
55112		 Add High Temperature Monitor to High Power Lean Line.
P010031/S342
12/20/12		 Concerto, Consulta, Consulta DF4, Insync III Marquis, and lnsync Maximo ICDs; and Concerto II, Maximo II, Protecta and Protecta XT CRT-D Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P010032/S064
12/4/12		 Eon Mini IPG Neuromodulation System St. Jude Medical
Plano, TX
75024		 Change to the electrode cutting process.
P010041/S037
12/10/12		 Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis, Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of a Quality Management System software.
P010041/S038
12/11/12		 Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis, Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of jar torque machines.
P010054/S021
12/20/12		 Elecsys® Anti-HBs Immunoassay and Elecsys® Preci-Control Anti-HBs Roche Diagnostics Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P020004/S076
12/5/12		 GORE EXCLUDER AAA Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001		 Removal of a final device acceptance test.
P020004/S077
12/13/12		 Gore Excluder AAA Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001		 Replication of a manufacturing line in Phoenix, Arizona.
P020004/S078
12/21/12		 Gore Excluder AAA Endoprosthesis with C3 Delivery System W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001		 Change to the parameters for bonding the olive to the catheter shaft.
P020004/S079
12/27/12		 Gore Excluder AAA Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001		 Revisions to the routine quality control testing conducted at a qualified supplier of polytetrafluor-ethylene (PTFE) and fluorinated ethylene propylene (FEP) laminated membranes.
P020004/S080
12/21/12		 GORE EXCLUDER AAA Endoprosthesis W. L. Gore & Associates, Inc.
Flagstaff, AZ 		Use an alternate raw material in the graft tube components of the EXCLUDER device.
P020009/S097
12/11/12		 Express and Express2 Coronary Stent Systems Boston Scientific Corporation
Maple Grove MN
55311		 Removal of a redundant step in the catheter assembly.
P020009/S098
12/11/12		 Express2 Monorail & Over-the-Wire Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Removal of two in-process inspections.
P020009/S099
12/13/12		 Express2 Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Change to the annealing temperatures for delivery catheters.
P020009/S100
12/11/12		 Express2 Coronary Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Use of an electronic records system.
P020009/S101
12/21/12		 Express2 Coronary Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Consolidate measurement and inspection steps onto the same manufacturing line.
P020018/S047
12/12/12		 Zenith AAA Endovascular Graft Cook Incorporated
Bloomington, IN
47402		 Lowering of the acceptance testing criterion for an in-process testing.
P020047/S053
12/5/12		 MULTI-LINK 8, 8SV and 8LL Coronary Stent System Abbott Vascular
Temecula, CA
92589		 Addition of a second sterilization chamber in Ireland.
P030005/S093
12/5/12		 Contak Renewal TR CRT-p Family Boston Scientific CRM
St. Paul, MN
55112		 Replace the traceability and tracking system.
P030017/S146
12/28/12		 Precision Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355		 Addition of an alternate supplier for a packaging component.
P030025/S099
12/11/12		 TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Use of an electronic records system.
P030025/S100
12/21/12		 TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Consolidate measurement and inspection steps onto the same manufacturing line.
P030026/S027
12/21/12		 VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626		 Change to the limits of an in-process test used in the assessment of streptavidin coated wells, a component of the device.
P030036/S052
12/20/12		 Anchoring Sleeve Kit and SelectSecure Lead Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P030054/S239
12/17/12		 Promote Family of CRT-Ds St. Jude Medical
Sunnyvale, CA
94086		 Modifications to automated manufacturing tests.
P040016/S102
12/11/12		 VeriFLEX Coronary Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Removal of a redundant step in the catheter assembly.
P040016/S103
12/11/12		 VeriFLEX Monorail and Over-the Wire Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Removal of two in-process inspections.
P040016/S104
12/13/12		 VeriFLEX (Liberté) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Change to the annealing temperatures for delivery catheters.
P040016/S105
12/11/12		 VeriFLEX (Liberté) Bare Metal Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Use of an electronic records system.
P040016/S106
12/21/12		 VeriFLEX (Liberté) Bare Metal Coronary Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Consolidate measurement and inspection steps onto the same manufacturing line.
P040043/S049
12/5/12		 GORE TAG THORACIC Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001		 Removal of a final device acceptance test.
P040043/S050
12/27/12		 Gore Tag Thoracic Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001		 Revisions to the routine quality control testing conducted at a qualified supplier of polytetrafluor-ethylene (PTFE) and fluorinated ethylene propylene (FEP) laminated membranes.
P040045/S034
12/27/12		 VISTAKON (senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256		 Implementation of an alternate new test method for lens monomer leachable.
P050006/S033
12/26/12		 Gore Helex Septal Occluder W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001		 Alternate resin raw material for the device.
P050019/S012
12/11/12		 Cartotid WALLSTENT Monorail Endoprosthesis Boston Scientific Corporation
Maple Grove MN
55311		 Use of an electronic records system.
P050034/S007
12/27/12		 Implantable Miniature Telescope VisionCare Ophthalmic Technologies
Saratoga, CA
95070		 Implementation of a holding system using nitrogen gas in Laser Welding System I (LWSI).
P050039/S014
12/5/12		 Exactech Novation Ceramic AHS Articulation Hip System Exactech, Inc.
Gainesville, FL
32653		 Addition of a package sealer.
P050042/S019
12/5/12		 ARCHITECT Anti- HCV Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P050042/S020
12/10/12		 ARCHITECT Anti- HCV Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P050042/S021
12/14/12		 ARCHITECT Anti-HCV Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P050046/S018
12/5/12		 ACUITY Steerable Heart Failure Lead Family Boston Scientific CRM
St. Paul, MN 
55112		 Replace the traceability and tracking system.
P050049/S011
12/5/12		 AxSYM HBsAg/ HBsAg Confirmatory Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P050051/S017
12/5/12		 ARCHITECT AUSAB Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P050051/S018
12/10/12		 ARCHITECT AUSAB Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P050051/S019
12/14/12		 ARCHITECT AUSAB Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P060003/S012
12/5/12		 AxSYM AUSAB Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P060006/S037
12/13/12		 Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Change to the annealing temperatures for delivery catheters.
P060006/S038
12/11/12		 Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Use of an electronic records system.
P060006/S039
12/21/12		 Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Consolidate measurement and inspection steps onto the same manufacturing line.
P060007/S023
12/5/12		 ARCHITECT HBsAg/HBsAg Confirmatory Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P060007/S024
12/10/12		 ARCHITECT HBsAg/
Confirmatory		 Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P060007/S025
12/14/12		 ARCHITECT HBsAg/
Confirmatory		 Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P060008/S099
12/11/12		 TAXUS Liberté Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Removal of a redundant step in the catheter assembly.
P060008/S100
12/11/12		 TAXUS Liberté Monorail and Over-the-Wire Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Removal of two in-process inspections.
P060008/S101
12/11/12		 TAXUS Liberté Paclitaxel-Eluting  Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Use of an electronic records system.
P06008/S102
12/21/12		 TAXUS Liberté Paclitaxel-Eluting  Coronary Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Consolidate measurement and inspection steps onto the same manufacturing line.
P060009/S007
12/5/12		 AxSYM CORE-M 2.0 Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P060012/S010
12/5/12		 AxSYM CORE Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
       
P060035/S016
12/5/12		 ARCHITECT CORE-M Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P060035/S017
12/10/12		 ARCHITECT CORE-M Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P060035/S018
12/14/12		 ARCHITECT CORE-M Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P060039/S039
12/20/12		 Attain StarFix Lead Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P060039/S040
12/26/12		 Attain Ability Lead Medtronic, Inc.
Mounds View, MN
55112		 Additional supplier for extruded tubing.
P070015/S104
12/5/12		 XIENCE V and XIENCE nano Everolimus Eluting Coronary Stcnt
System		 Abbott Vascular
Temecula, CA
92589		 Addition of a second sterilization chamber in Ireland.
P080006/S047
12/20/12		 Attain Ability Lead Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P080006/S048
12/26/12		 Attain StarFix Lead Medtronic, Inc.
Mounds View, MN
55112		 Additional supplier for extruded tubing.
P080011/S019
12/5/12		 Biofinity (comfilcon A) Soft (Hydrophilic) Extended-Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588		 Revalidation of manufacturing equipment.
P080014/S014
12/14/12		 Cervista® HPV HR Hologic LP
Marlborough, MA
01752		 Add an alternative manufacturing process method to the current method for the device.
P080023/S017
12/5/12		 ARCHITECT CORE Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P080023/S018
12/10/12		 ARCHITECT CORE Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P080023/S019
12/14/12		 ARCHITECT CORE Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P080032/S011
12/11/12		 Alair Bronchial Thermoplasty System Boston Scientific Corporation
Sunnyvale, CA
94089		 Implementation of change related to the sterilization of the catheter which is used with the device.
P090003/S019
12/11/12		 Express LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Use of an electronic records system.
P090003/S020
12/21/12		 Express LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Consolidate measurement and inspection steps onto the same manufacturing line.
P090007/S011
12/20/12		 Elecsys® Anti-HCV Immunoassay and Elecsys® Preci-Control Anti-HCV for use on the
cobas e 411 Immunoassay Analyzer 		Roche Diagnostics Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P090008/S012
12/20/12		 Elecsys® Anti-HCV Immunoassay and Elecsys® Preci-Control Anti-HCV for use on the
cobas e 601 Immunoassay Analyzer		 Roche Diagnostics Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P090009/S011
12/20/12		 Elecsys® Anti-HCV Immunoassay and Elecsys® Preci-Control Anti-HCV for use on the
MODULAR
ANALYTICS El70 Immunoassay Analyzer		 Roche Diagnostic Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P090013/S080
12/4/12		 Revo MRI IPG Medtronic, Inc.
Mounds View, MN
55112		 Update to the battery burn-in process and inspection methods.
P090013/S081
12/20/12		 CapSureFix MRI Lead and Revo MRI IPG Medtronic, Inc.
Mounds View, MN
55112		 Implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P090028/S006
12/21/12		 VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626		 Change to the limits of an in-process test used in the assessment of streptavidin coated wells, a component of the devices.
P100001/S005
12/21/12		 VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626		 Change to the limits of an in-process test used in the assessment of streptavidin coated wells, a component of the devices.
P100013/S007
12/13/12		 ExoSeal Vascular Closure Device Cordis Corporation
Bridgewater, NJ
08807		 Alternate sterilization minimum dose.
P100013/S008
12/28/12		 Exoseal Vascular Closure Device Cordis Corporation
Bridgewater, NJ
08807		 Use of an alternate component supplier.
P100014/S008
12/19/12		 Solesta Injectable Gel Salix Pharmaceuticals, Inc.
Raleigh, NC
27615		 Change the method of verification of printed information on the product labels.
P100023/S063
12/11/12		 ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Removal of two in-process inspections.
P100023/S064
12/13/12		 ION (TAXUS Element)  Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Change to the annealing temperatures for delivery catheters.
P100023/S065
12/11/12		 ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Use of an electronic records system.
P100023/S066
12/21/12                  		ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Consolidate measurement and inspection steps onto the same manufacturing line.
P100031/S010
12/20/12		 Elecsys® Anti-HBc Immunoassay and Elecsys® Preci-Control Anti-HBc for use on the MODULAR
ANALYTICS E170 Immunoassay Analyzer 		Roche Diagnostics Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P100032/S008
12/20/12		 Elecsys® Anti-HBc Immunoassay and Elecsys®  Preci-Control Anti-HBc for use on the
Elecsys® 2010 Immunoassay Analyzer 		Roche Diagnostics Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P100041/S016
12/10/12		 Edwards SAPIEN Transcatheter Heart Valve and Accessories, RetroFlex3 Delivery System, RetroFlex Balloon Catheter, Edwards Transfemoral Balloon Catheter, Crimper Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of a Quality Management System software.
P100041/S017
12/11/12		 Edwards SAPIEN Transcatheter Heart Valve and Accessories, RetroFlex3 Delivery System, RetroFlex Balloon Catheter, Edwards Transfemoral Balloon Catheter, Crimper Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of jar torque machines.
P100047/S001
12/21/12		 Heartware Left Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL
33014		 Change to supplier of an electronic component.
P100047/S002
12/26/12		 Heartware Left Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL
33014		 Change to supplier of an electronic component.
P100047/S003
12/27/12		 Heartware Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL
33014		 Process change in the manufacturing and assembly of the driveline connector.
P100047/S006
12/19/12		 HeartWare Ventricular Assist Device HeartWare, Inc.
Miami Lakes, FL
33014		 Outsourcing several components of the HeartWare System for the polishing process.
P10047/S0007
12/28/12		 HeartWare Ventricular Assist Device HeartWare, Inc.
Miami Lakes, FL
33014		 Reductions to sampling plans and modification to incoming inspection.
P100047/S009
12/18/12		 HeartWare Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL
33014		 Use of alternate automated inspection equipment for a critical component.
P110010/S038
12/11/12		 PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Removal of two in-process inspections.
P110010/S039
12/13/12		 PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Change to the annealing temperatures for delivery catheters.
P110010/S040
12/11/12		 PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Use of an electronic records system.
P110010/S041
12/19/12		 PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311		 Software modifications to the balloon manufacturing equipment.
P110010/S042
12/21/12		 PROMUS Element Plus Everolimus-Eluting Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Consolidate measurement and inspection steps onto the same manufacturing line.
P110012/S002
12/26/12		 Vysis ALK Break Apart FISH Probe Kit Abbott Molecular, Inc.
Des Plaines, IL
60018		 Qualify the GENEPREP instrument, qualify the overhead mixing system and validate the mixing process in the manufacture of the hybridization buffer, and transfer an existing in-process testing of labeled DNA.
P110019/S037
12/5/12		 XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary
Stent System		 Abbott Vascular
Temecula, CA
92589		 Addition of a second sterilization chamber in Ireland.
P110021/S001
12/10/12		 Edwards SAPIEN Transcatheter Heart Valve and Accessories, RetroFlex3 Delivery System, RetroFlex Balloon Catheter, Edwards Transfemoral Balloon Catheter, Crimper Ascendra Balloon Catheter, Ascendra Balloon Aortic Valvuloplasty Catheter, Ascendra Introducer Sheath Set Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of a Quality Management System software.
P110021/S002
12/11/12		 Edwards SAPIEN Transcatheter Heart Valve and Accessories, RetroFlex3 Delivery System, RetroFlex Balloon Catheter, Edwards Transfemoral Balloon Catheter, Crimper Ascendra Balloon Catheter, Ascendra Balloon Aortic Valvuloplasty Catheter, Ascendra Introducer Sheath Set Edwards Lifesciences, LLC
Irvine, CA
92614		 Use of jar torque machines.
P110022/S009
12/20/12		 Elecsys® Anti-HBc IgM Immunoassay and Elecsys® Preci-Control Anti-HBc IgM for use on the cobas e 601 Immunoassay Analyzer Roche Diagnostics Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P110025/S008
12/20/12		 Elecsys® Anti-HBc IgM Immunoassay and Elecsys® Preci-Control Anti-HBc IgM for use on the MODULAR ANALYTICS E170
Immunoassay Analyzer 		Roche Diagnostics Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P110029/S008
12/5/12		 ARCHITECT HBsAg Qualitative/ HBsAg Qualitative Confirmatory Abbott Laboratories
Abbott Park, IL
60064		 Change to the Quality Control Method for a vendor-supplied detergent.
P110029/S009
12/10/12		 ARCHITECT HBsAg Qualitative/ Confirmatory Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P110029/S010
12/14/12		 ARCHITECT HBsAg Qualitative/ Confirmatory Abbott Laboratories
Abbott Park, IL
60064		 Add a quality control test for an incoming raw material.
P110031/S008
12/20/12		 Elecsys® Anti-HBc IgM Immunoassay and Elecsys® Preci-Control Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer Roche Diagnostics Corporation
Indianapolis, IN
46250		 Transfer of the final packaging process to a different line within the Mannheim, Germany site and to change the box and spacer element size, main and side label
size and label layout.
P110035/S005
12/11/12		 Epic Vascular Self-Expanding Stent System Boston Scientific Corporation
Maple Grove MN
55311		 Use of an electronic records system.
P110042/S001
12/5/12		 Subcutaneous Implantable Defibrillator S-ICD System Cameron Health, Inc.
San Clemente, CA
92673		 Change to the header preparation and attachment process.

Summary of PMA Originals & Supplements Approved
Originals: 1                                                                 
Supplements: 73                                                                     

Summary of PMA Originals Under Review
Total Under Review: 52                                                        
Total Active: 23                                                                     
Total On Hold: 29                                                                                          

Summary of PMA Supplements Under Review
Total Under Review: 535                                                      
Total Active: 361                                           
Total On Hold: 174                                                                                        

Summary of All PMA Submissions Received
Originals: 3                                                                 
Supplements: 92                                                                     

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 73                                                      
Number of Denials: 0                                                 
Average Days Fr Receipt to Decision (Total Time): 174         
FDA Time: 110.5 Days      MFR Time: 63.5 Days

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