FDA releases June 2013 PMA approvals

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Summary of PMA Originals & Supplements Approved 
Originals: 2
Supplements: 93

Summary of PMA Originals Under Review 
Total Under Review: 58    
Total Active: 26
Total On Hold: 32    

Summary of PMA Supplements Under Review 
Total Under Review: 570  
Total Active: 407  
Total On Hold: 163   

Summary of All PMA Submissions Received
Originals: 5  
Supplements: 68

Summary of PMA Supplement PMA Approval/Denial Decision Times 
Number of Approvals: 93  
Number of Denials: 0 
Average Days Fr Receipt to Decision (Total Time): 121.3       
FDA Time: 102.2 Days    MFR Time: 19.1 Days

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P060028
6/14/13
MemoryShape™ Breast Implants (Style MM or Style 321) Mentor Worldwide LLC
Santa Barbara, CA 93111
Approval for the MemoryShape™ Breast Implants. This device is indicated for females for the following uses (procedures): 1) Breast augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery; and 2) Breast Reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.
P120012
6/20/13
Abbott RealTime HCV Genotype II
Abbott RealTime HCV Genotype II Control Kit Uracil-N-Glycosylase (UNG)
Abbott Molecular, Inc.
Des Plaines, IL 60018
Approval for the Abbott RealTime HCV Genotype II, Abbott RealTime HCV Genotype II Control Kit, and Uracil-Glycosylase (UNG). This device is indicated for: Abbott RealTime HCV Genotype II The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the Abbott mSample Preparation System reagents and with the Abbott m2000sp and m2000rtinstruments for the qualitative identification of hepatitis C virus (HCV) genotypes 1, 1a, 1b, and 2 – 5 in plasma or serum from individuals chronically infected with HCV. The Abbott RealTime HCV Genotype II is intended for use as an aid in the management of HCV-infected individuals and in guiding the selection of therapeutic treatment indicated for the above listed genotypes. The assay is intended for use on patients who are chronically infected with HCV, are being considered for antiviral treatment, and are positive for HCV RNA. The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV. Abbott RealTime HCV Genotype II Control Kit The Abbott RealTime HCV Genotype II Controls are used to establish run validity of the Abbott RealTime HCV Genotype II assay when used for determining the genotype(s) of hepatitis C virus (HCV) in plasma or serum from individuals chronically infected with HCV. Uracil-N-Glycosylase (UNG) The Uracil-N-Glycosylase (UNG) procedure is to be used in conjunction with Abbott RealTime HCV Genotype II assay as an optional contamination control for customer laboratories that are currently using or have previously used amplification technologies that incorporate uracil into the amplification product.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N18286/S025
6/3/13
Special
Gelfoam (Absorbable Gelatin Powder) Pfizer, Inc
Bristol, TN
37681
Approval for label changes to the instructions for use: 1) For the following device iterations: Gelfoam Plus -Original Sponge IFU- Needleless; Gelfoam Plus- Powder IFU-Needleless; Gelfoam Plus – Compressed Sponge IFU – Needleless; Gelfoam (absorbable gelatin) Sponge; Gelfoam (absorbable gelatin) Dental Sponge; Gelfoam (absorbable gelatin) Compressed Sponge; and Gelfoam (absorbable gelatin) Powder. Add the precautionary statement: “Positioning of the patient resulting in negative peripheral venous pressure during a procedure has been reported to be a contributing factor resulting in life-threatening thromboembolic events.” 2) For the following device iterations: Gelfoam (absorbable gelatin) Sponge; Gelfoam (absorbable gelatin) Dental Sponge; Gelfoam (absorbable gelatin) Compressed Sponge; and Gelfoam  (absorbable gelatin) Powder. Make minor changes to the existing precautionary statement: “Although the safety and efficacy of the combined use of GELFOAM with other agents such as topical thrombin has not been evaluated in Pharmacia- controlled clinical trials, if in the physician’s judgment concurrent use of topical thrombin other agents is medically advisable, the product literature for that agent should be consulted for complete prescribing information.”
P820003/S120
6/11/13
Real-Time
Pasys, Pasys ST, Spectrax S, Spectrax SX, Spectrax SX-HT, Spectrax SXT, Symbios, Symbios (Aa), Synergyst Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P830055/S134
6/11/13
180-Day
LCS Total Knee System DePuy Orthopaedics, Inc. 
Warsaw, IN
46581
Approval for a manufacturing site located at STERIS Isomedix in Chester, New York.
P840001/S234
6/19/13
180-Day
Restore Ultra Neurostimulator, Restore Sensor Neurostimulator, Itrel 4 Neurostimulator, RestoreAdvancedMRI, PrimeAdvanced-MRI, RestoreUltraMRI, 
RestoreSensorMRI and External Neurostimulator
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for firmware changes intended to correct device behaviors that result in temporary loss of stimulation (Exception Bit) and can affect programmed stimulation parameters (Over-Discharge).
P840001/S235
6/17/13
135-Day
Spinal Cord Stimulation (Itrel, Synergy, Synergy Versitrel, Restore,
RestorePrime, Restore Advanced, Prime Advanced, Restore Ultra, ENS)
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for a change to a software-based system for incoming inspection.
P850048/S033
6/7/13
Real-Time
Access Hybritech PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc. 
Chaska, MN 
55318
Approval for modification of a sample probe used in the UniCel DxI 600, 800 and the UniCel DxC 660i, 680i, 860i, and 880i.
P850051/S080
6/11/13
Real-Time
Activitrax, Activitrax II, Activitrax E, Legend, Legend II, Micro Minix, Minix, Minix ST, Premier, Prevail, Vitatron Legacy Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P860004/S187
6/18/13
Real-Time
N Vision Programmer, 
N Vision Software Application Card
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for N Vision Programmer (Model 8840) and N Vision Software Application Card (Model 8870).
P860057/S100
6/11/13
180-Day
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, 
Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis,  
Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis, 
Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis, 
Carpentier-Edwards PERIMOUNT Magna Mitral Pericardial Bioprosthesis, Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis, 
Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis
Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for the use of the re-designed and re-programmed SensiTech TagAlert Temperature Alarm Indication with new Electromagnetic Inference/Electromagnetic Discharge (EMI/ESE) protection in the devices.
P860057/S108
6/10/13
Special
Carpentier-Edwards Pericardial Bioprosthesis, Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles during the tissue isolation manufacturing process.
P870056/S056
6/11/13
180-Day
Carpentier-Edwards Porcine Aortic Bioprosthesis,  
Carpentier-Edwards Porcine Mitral Bioprosthesis
Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for the use of the re-designed and re-programmed SensiTech TagAlert Temperature Alarm Indication with new Electromagnetic Inference/Electromagnetic Discharge (EMI/ESE) protection in the devices.
P870072/S053
6/21/13
Real-Time
Thoratec® Ventricular Assist Device System Thoratec Corporation 
Pleasanton, CA 94588
Approval for the change in secondary packaging of the VAD sealed arterial cannula and the intermediate bulk shipment configuration.
P870077/S051
6/11/13
180-Day
Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis,  Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended Suture Ring Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for the use of the re-designed and re-programmed SensiTech TagAlert Temperature Alarm Indication with new Electromagnetic Inference/Electromagnetic Discharge (EMI/ESE) protection in the devices.
P890003/S273
6/11/13
Real-Time
Elite, Elite II, Minuet, Preva, Preva D, Prodigy, Synergyst II, Thera, Thera-I, Vitatron Legacy, Vitatron Legacy II, Model 2090 Carelink Programmer Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P900061/S121
6/11/13
Real-Time
Gem, Jewel, Micro Jewel, Jewel Plus, Micro Jewel II, PCD Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P910077/S134
6/20/13
Real-Time
ZOOM® LATITUDE® Programming System Boston Scientific Corporation
St. Paul, MN 
55112
Approval for use of an alternate antenna (Model 3123) with the LATITUDE Programmer/ Recorder/Monitor Model 3120 and associated device labeling.
P930016/S038
6/27/13
Special
WaveScan WaveFront System AMO Manufacturing USA, LLC 
Milpitas, CA 
95035
Approval for changes to the WaveScan WaveFront System device labeling (User Manual).
P930022/S015
6/11/13
Real-Time
Legend Plus Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P930031/S040
6/18/13
135-Day
WALLSTENT (TIPS) Endoprosthesis Boston Scientific Corporation
Maple Grove, MN 55311
Approval for use of an alternate PTFE material.
P940019/S035
6/18/13
135-Day
WALLSTENT (Iliac) Endoprosthesis Boston Scientific Corporation
Maple Grove, MN 55311
Approval for use of an alternate PTFE material.
P950005/S041
6/6/13
180-Day
Bi-Directional Celsius FLTR Biosense Webster, Inc. 
Diamond Bar, CA 91765
Approval for modified catheter designs to the 7Fr Celsius and 7Fr EZ Steer DS Catheters to create the 7.5Fr 8 mm Celsius FLTR Catheters. The changes being approved are the increased distal profile, larger curve profile, increased range of deflection, and increased deflectable tip diameter. The devices, as modified, will be marketed under the trade names Bi-Directional Celsius FLTR catheters (D-1359-XX-S) and Uni-Directional Celsius FLTR catheters (D-1355-XX-S) and are indicated for catheter-based cardiac electrophysiological mapping (stimulation and recording), and when used with the Stockert 70 (with software version 001/033 or higher) for the treatment of Type I atrial flutter in patients age 18 years of age or older.
P950020/S055
6/28/13
180-Day
Flextome® Coronary Cutting Balloon® Boston Scientific Corporation
Maple Grove, MN 55311
Approval for Directions for Use (DFU) labeling modifications.
P950020/S061
6/21/13
Real-Time
Flextome® Coronary Cutting Balloon® Boston Scientific Corporation
Maple Grove, MN 55311
Approval to manufacture the Flushing Needle (also known as Tip Barrell 30 Gauge) accessory with an alternative resin provided by a new supplier.
P950029/S079
6/20/13
180-Day
Reply, Espirit SR and DR Model Pacemakers Sorin Group USA, Inc.
Arvada, CO
80004
Approval for a modification to the flex circuit hybrid component and approval for an alternate supplier.
P950032/S073
6/25/13
180-Day
Apligraf Organogenesis Inc. 
Canton, MA
02021
Approval for a manufacturing site located in Canton, Massachusetts.
P960009/S165
6/19/13
180-Day
Activa PC Neurostimulator, Activa SC Neurostimulator, Activa RC Neurostimulator, and External Neurostimulator Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for firmware changes intended to correct device behaviors that result in temporary loss of stimulation (Exception Bit) and can affect programmed stimulation parameters (Over-Discharge).
P960009/S166
6/17/13
135-Day
Activa Deep Brain Stimulation (Activa PC, Activa SC, Activa RC,
Kinetra, Soletra)
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for a change to a software-based system for incoming inspection.
P960009/S170
6/3/13
135-Day
Activa Tremor Control System Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for the implementation of change to manufacturing molding process and additional inspectional steps, for the device.
P960042/S043
6/14/13
180-Day
Spectranetics Laser Sheath Kits (SLSII and GlideLight Spectranetics Corporation
Colorado Springs, CO 
80921
Approval for a material change to the inner liner of the devices.
P970004/S151
6/17/13
135-Day
Interstim Therapy for Urinary Control Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for a change to a software-based system for incoming inspection.
P970012/S093
6/11/13
Real-Time
Kappa 400 Series of Pulse Generators Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P970021/S038
6/20/13
Real-Time
GYNECARE® THERMA-CHOICE® III Uterine Balloon Therapy System ETHICON, Inc. – Women’s Health and Urology 
Somerville, NJ 08876
Approval for a change in pressure transducer.
P970038/S022
6/7/13
Real-Time
Access Hybritech free PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc. 
Chaska, MN 
55318
Approval for modification of a sample probe used in the UniCel DxI 600, 800 and the UniCel DxC 660i, 680i, 860i, and 880i.
P970051/S108
6/12/13
135-Day
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO 80111
Approval for modification to the cleaning process for intracochlear electrodes.
P980016/S413
6/11/13
Real-Time
EnTrust, Gem, Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Protecta DF4, Protecta, Protecta XT DF4, Protecta XT, Secura DF4, Secura, Virtuoso, Virtuoso II, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P980031/S012
6/3/13
135-Day
INTACS Corneal Implants Addition Technology
Lombard, IL
60148
Approval for the transfer of distribution, product release, secondary labeling and packaging, and limited secondary labeling and secondary packaging rework operations from the firm’s current facility to its new facility.
P980033/S029
6/18/13
135-Day
WALLSTENT (Venous) Endoprosthesis Boston Scientific Corporation
Maple Grove, MN 55311
Approval for use of an alternate PTFE material.
P980035/S320
6/18/13
Real-Time
Adapta, Versa, Sensia, and Relia Medtronic, Inc. 
Mounds View, MN 55112
Approval for changes to the burn-in specifications of the batteries used in the cardiac pacemakers.
P980035/S321
6/11/13
Real-Time
Adapta, Advisa, AT500, EnPulse, EnRhythm, Kappa 600, Kappa 650, Kappa 700, Kappa 800, Kappa 900, Relia, Sensia, Sigma, Versa Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P980041/S023
6/7/13
Real-Time
Access AFP Reagents on the Access Immunoassay Systems Beckman Coulter, Inc. 
Chaska, MN 
55318
Approval for modification of a sample probe used in the UniCel DxI 600, 800 and the UniCel DxC 660i, 680i, 860i, and 880i.
P980050/S082
6/11/13
Real-Time
Jewel AF, GEM III AT Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P990001/S111
6/11/13
Real-Time
Diva family (includes Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR), Dema family (includes Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita II DDDR and Vita II), Selection AFm, 
C-series Devices, 
T-series Devices
Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P990009/S036
6/19/13
Special
Floseal Hemostatic Matrix Baxter Healthcare Corporation
Round Lake, IL 60073
Approval for inclusion of an additional precaution statement in the Instructions for Use for the Floseal Hemostatic Matrix (‘FLOSEAL’).
P990046/S028
6/28/13
180-Day
Open Pivot Heart Valve Medtronic Inc.
Mounds View, MN
55112
Approval for a manufacturing site located in Minneapolis, Minnesota.
P990046/S032
6/7/13
180-Day
Open Pivot Heart Valve Medtronic Inc.
Mounds View, MN 55112
Approval for a manufacturing site located in  Minneapolis, Minnesota.
P000007/S038
6/11/13
180-Day
Edwards Prima Plus Stentless Porcine Bioprosthesis Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for the use of the re-designed and re-programmed SensiTech TagAlert Temperature Alarm Indication with new Electromagnetic Inference/Electromagnetic Discharge (EMI/ESE) protection in the devices.
P000025/S063
6/6/13
180-Day
MED-EL Cochlear Implant System MED-EL Corporation 
Durham, NC 
27713
Approval for new labeling that describes conditions for safe magnetic resonance (MR) imaging at 0.2 and 1.5 Tesla field strengths and radiation therapy of patients implanted with the MED-EL cochlear implant systems which include the PULSARCI100, SONATATI100, MED-EL CONCERT, MED-EL CONCERT PIN implants.
P010014/S043
6/25/13
180-Day
Oxford Partial Knee System Biomet, Inc. 
Warsaw, IN 
46581
Approval for a manufacturing site located at Biomet, Inc., in Warsaw, Indiana.
P010015/S198
6/11/13
Real-Time
Consulta CRT-P, InSync, InSync III, Syncra CRT-P Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P010030/S040
6/24/13
135-Day
Lifevest Wearable Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA 15238
Approval for the addition of an alternate supplier of an electrode component used in the device.
P010031/S373
6/11/13
Real-Time
Concerto, Concerto II CRT-D, Consulta CRT-D, InSync ICD, InSync II Marquis, InSync II Protect, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II CRT-D, Maximo II DF4, Protecta CRT-D, Protecta DF4, Protecta XT CRT-D, Brava CRT-D, Viva S CRT-D, Viva XT CRT-D, Protecta XT DF4 Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P010032/S050
6/26/13
135-Day
Genesis, Eon, Eon C, Eon Mini, Neuromodulation Systems St. Jude Medical 
Plano, TX
75024
Approval for the addition of several pieces of equipment that are new to the manufacturing process as well as the relocation of equipment and the addition of an already approved piece of equipment to the Bilby Road Facility location.
P010038/S017
6/19/13
180-Day
Fuji Aspire HD Full-Field Digital Mammography (FFDM) System iCAD, Inc.
Nashua, NH 
03062
Approval of SecondLook V7.2 CAD for use with the Fuji Aspire HD full-field digital mammography (FFDM) system
P010041/S040
6/11/13
180-Day
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for the use of the re-designed and re-programmed SensiTech TagAlert Temperature Alarm Indication with new Electromagnetic Inference/Electromagnetic Discharge (EMI/ESE) protection in the devices.
P010068/S031
6/6/13
180-Day
Uni-Directional Celsius FLTR Catheter Biosense Webster, Inc. 
Diamond Bar, CA 91765
Approval for modified catheter designs to the 7Fr Celsius and 7Fr EZ Steer DS Catheters to create the 7.5Fr 8 mm Celsius FLTR Catheters. The changes being approved are the increased distal profile, larger curve profile, increased range of deflection, and increased deflectable tip diameter. The devices, as modified, will be marketed under the trade names Bi-Directional Celsius FLTR catheters (D-1359-XX-S) and Uni-Directional Celsius FLTR catheters (D-1355-XX-S) and are indicated for catheter-based cardiac electrophysiological mapping (stimulation and recording), and when used with the Stockert 70 (with software version 001/033 or higher) for the treatment of Type I atrial flutter in patients age 18 years of age or older.
P020009/S104
6/21/13
Real-Time
Express2 Coronary Stent System Boston Scientific 
Maple Grove, MN 55311
Approval to manufacture the Flushing Needle (also known as Tip Barrell 30 Gauge) accessory with an alternative resin provided by a new supplier.
P030017/S148
6/28/13
135-Day
Precision Spinal Cord Stimulator (SCS) System Boston Scientific Neuromodulation
Valencia, CA
91355
Approval for a change in location of your Implantable Pulse Generator (IPG) Case supplier.
P030027/S006
6/20/13
135-Day
Ceramic TRANSCEND® Articulation System Wright Medical Technology, Inc.
Arlington, TN 38002
Approval to replace manual washing of ceramic components with an automated washer.
P040002/S041
6/17/13
Real-Time
AFX AAA Endovascular System Endologix, Inc. 
Irvine, CA 
92618
Approval for the addition of a release sleeve to the proximal extension accessory stent graft delivery system. The device, as modified, will be marketed under the trade name AFX Vela Proximal Endograft System.
P040016/S110
6/21/13
Real-Time
VeriFLEX (Liberte) Coronary Stent System Boston Scientific 
Maple Grove, MN 55311
Approval to manufacture the Flushing Needle (also known as Tip Barrell 30 Gauge) accessory with an alternative resin provided by a new supplier.
P040021/S023
6/3/13
Real-Time
Biocor/Epic™ Valve St. Jude Medical 
St. Paul, MN 
55117
Approval for a change to the valve holder force specification.
P060006/S043
6/21/13
Real-Time
Express SD Renal Premounted Stent System Boston Scientific 
Maple Grove, MN 55311
Approval to manufacture the Flushing Needle (also known as Tip Barrell 30 Gauge) accessory with an alternative resin provided by a new supplier.
P060040/S026
6/3/13
Real-Time
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation 
Pleasanton, CA 94588
Approval for design and manufacturing changes to the 14 Volt Battery Clip LEMO Connector Housing.
P070006/S009
6/12/13
135-Day
T-SPOT®.TB Test Oxford Immunotec Ltd.
Toms River, NJ 08754
Approval for the addition of a second approved supplier for the conjugated secondary antibody
P070015/S108
6/7/13
180-Day
XIENCE Nano Everolimus Eluting Coronary Stent System Abbott Vascular 
Santa Clara, CA 95054
Approval of the post-approval study protocol.
P080012/S013
6/3/13
Real-Time
Prometra Programmable Infusion System Flowonix Medical, Incorporated 
Mt. Olive, NJ 
07828
Approval for adding an alternate sub-tier supplier and material change for the molded silicone suture wings (straight and 90 degree) that are supplied in the Catheter Kit.
P080025/S047
6/17/13
135-Day
Interstim Therapy for Bowel Control Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for a change to a software-based system for incoming Inspection.
P080032/S013
6/3/13
180-Day
Alair Bronchial Thermoplasty System Boston Scientific Corporation 
Marlborough, MA 01752
Approval for a manufacturing site located at Boston Scientific Corporation, in Quincy, Massachusetts for assembly of the controller accessory kit.
P090013/S093
6/11/13
Real-Time
Revo MRI, EnRhythm MRI Medtronic, Inc. 
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic Carelink Programmer for the devices.
P090018/S020
6/6/13
Special
Esteem® Implantable Hearing System Envoy Medical Corporation 
St Paul, MN 
55110
Approval for addition of technical notes to expand upon the  information in the Audiologist’s Manual and to remind surgeons and audiologists of the importance of reporting significant injuries to cranial nerve VII via the Medical Device Reporting system.
P090026/S006
6/7/13
Real-Time
Access Hybritech P2PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc. 
Chaska, MN 
55318
Approval for modification of a sample probe used in the UniCel DxI 600, 800 and the UniCel DxC 660i, 680i, 860i, and 880i.
P100005/S002
6/19/13
180-Day
M-Vu Algorithm Engine VuCOMP, Inc.
Plano TX 
75093
Approval of M-Vu Algorithm Engine version 2.1.2.0 for use with the Fuji FCRm computed radiography (CR) full-field digital mammography (FFDM) system.
P100010/S022
6/7/13
Real-Time
Artic Front and Artic Front Advance Cardiac CryoAblation Catheters Medtronic CryoCath LP
Mounds View, MN 55112
Approval for minor updates to the component specification of the bilumen vacuum tube.
P100010/S024
6/20/13
Real-Time
Arctic Front and Arctic Front Advance Cardiac CryoAblation Catheters Medtronic, Inc. 
Mounds View, MN 55112
Approval to remove the planarity specification and associated final device “out-of-plane”  measurement.
P100020/S004
6/25/13
180-Day
Roche Cobas® HPV Test Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for processing of residual cervical sample directly from the PreservCyt™ vial (Hologic, Inc., Bedford, MA) after processing for liquid-based cytology (LBC) using either the Hologic ThinPrep® 2000 or ThinPrep® 3000 processors and testing on the cobas® 4800 system directly from the PreservCyt vial (primary vial). Approval for capability to add optional non-IVD software to the cobas® 4800 system that is used to perform the cobas® HPV Test was also requested.
P100022/S001
6/3/13
180-Day
Zilver PTX Drug-Eluting Peripheral Stent Cook Incorporated 
Bloomington, IN 47402
Approval for a product line extension for the Zilver PTX Drug-Eluting Peripheral Stent. This line extension includes additional stent lengths of 100mm and 120mm.
P100023/S072
6/21/13
Real-Time
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific 
Maple Grove, MN 55311
Approval to manufacture the Flushing Needle (also known as Tip Barrell 30 Gauge) accessory with an alternative resin provided by a new supplier.
P100041/S019
6/11/13
180-Day
Edwards SAPIEN Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for the use of the re-designed and re-programmed SensiTech TagAlert Temperature Alarm Indication with new Electromagnetic Inference/Electromagnetic Discharge (EMI/ESE) protection in the devices.
P100041/S028
6/10/13
Special
Edwards SAPIEN Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles during the tissue isolation manufacturing process.
P100044/S006
6/10/13
180-Day
Propel Mini sinus implant Intersect ENT 
Palo Alto, CA 94303
Approval for a manufacturing site located at Intersect ENT, in Menlo Park, California.
P110006/S001
6/27/13
180-Day
somo.v™ Automated Breast Ultrasound System (ABUS) U-Systems, Inc. 
Sunnyvale, CA 94085
Approval for a new transducer, new pre-set compression assist function, and other software and computer hardware changes. The device, as modified, will be marketed under the trade name Invenia ABUS and is indicated as an adjunct to mammography for breast cancer screening in asymptomatic woman for whom screening mammography findings are normal or benign (BI-RADS Assessment Category 1 or 2), with dense breast parenchyma (BI-RADS Composition/ Density 3 or 4), and have not had previous clinical breast intervention. The device is intended to increase breast cancer detection in the described patient population. The Invenia ABUS may also be used for diagnostic ultrasound imaging of the breast in symptomatic women.
P110010/S051
6/21/13
Real-Time
PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific 
Maple Grove, MN 55311
Approval to manufacture the Flushing Needle (also known as Tip Barrell 30 Gauge) accessory with an alternative resin provided by a new supplier.
P110019/S039
6/28/13
180-Day
XIENCE Xpedition Stent System Abbott Vascular
Temecula, CA 
92589
Approval for a manufacturing site located at Abbott Vascular Costa Rica (A VCR) in El Coyo Alajuela, Costa Rica.
P110021/S005
6/11/13
180-Day
Edwards SAPIEN Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for the use of the re-designed and re-programmed SensiTech TagAlert Temperature Alarm Indication with new Electromagnetic Inference/Electromagnetic Discharge (EMI/ESE) protection in the devices.
P110021/S014
6/10/13
Special
Edwards SAPIEN Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC 
Irvine, CA 
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles during the tissue isolation manufacturing process.
P110032/S002
6/17/13
Real-Time
Aorfix™ AAA Flexible Stent Graft System with Aorflex™ Delivery System Lombard Medical Technologies, Inc. 
Tempe, AZ 
85284
Approval for several modifications to the outer sheath of the delivery system. The device, as modified, will be marketed under the trade name Aorfix™ AAA Flexible Stent Graft System with Aorflex™ Delivery System and is indicated for treatment of patients with abdominal aortic and aorto-iliac aneurysms having vascular morphology suitable for endovascular repair, including: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, implants, and accessories; 2) Aortic neck landing zone diameters with a range of 19mm to 29mm; 3) Non aneurysmal proximal neck center-line length of ≥ 15mm;  4) Infrarenal aortic neck angulations including those up to and including 90°; 5) Common iliac landing zone diameters with a range of 9mm to 19mm; and 6) Distal fixation length of ≥ 15mm.
P110035/S012
6/6/13
Real-Time
Epic™ Vascular Self-Expanding Stent System Boston Scientific Corp. 
Maple Grove, MN 55311
Approval for a change in the stent length specification and changes to the product labeling which included a change to the labeled length of the stent and minor editorial modifications.

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
N17600/S027
6/27/13
Avitene® Ultrafoam® Microfibrillar Collagen Hemostat Sponge Davol Inc. 
Warwick, RI 
02886
Revised LAL (endotoxin) test for the Avitene® Ultrafoam® Microfibrillar Collagen Hemostat Sponge manufactured at the Woburn, Massachusetts site.
N970003/S151
6/6/13
INSIGNIA, ALTRUA, INGENIO, ADVANTIO Families of
Pacemakers
Boston Scientific Corporation
St. Paul, MN 
55112
Alternate sterilization cycle to reduce the evacuation dwell time during the EO removal phase.
P810002/S086
6/28/13
St. Jude Medical Mechanical Heart Valves St. Jude Medical
St. Paul, MN 
55117
Change in dimensional inspection equipment used to inspect leaflets used in the St. Jude Medical mechanical heart valves.
P810006/S037
6/3/13
Collastat – Absorbable Collagen Hemostatic Sponge, Collastat –
Absorbable Collagen Hemostatic Agent- Microfibrillar Form
Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Change in bioburden test method and a new testing laboratory.
P810006/S038
6/10/13
Collastat – Absorbable Collagen Hemostatic Sponge, Collastat –
Absorbable Collagen Hemostatic Agent- Microfibrillar Form
Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Implementation of Sampling Plan Analyzer software.
P810006/S039
6/18/13
Collastat – Absorbable Collagen Hemostatic Sponge, Collastat –
Absorbable Collagen Hemostatic Agent- Microfibrillar Form
Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Changes in cleaning detergent, dirty equipment hold times, and cleaning methods.
P810006/S040
6/20/13
Collastat – Absorbable Collagen Hemostatic Sponge, Collastat –
Absorbable Collagen Hemostatic Agent- Microfibrillar Form
Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Implementation of a replacement portable chiller.
P810006/S041
6/19/13
Collastat – Absorbable Collagen Hemostatic Sponge, Collastat –
Absorbable Collagen Hemostatic Agent- Microfibrillar Form
Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Proposed modifications to a finished goods acceptance test for collagen and qualification of associated process equipment.
P810006/S042
6/20/13
Collastat – Absorbable Collagen Hemostatic Sponge; COLLASTAT Absorbable Collagen Hemostatic Agent – Microfibrillar Form; Instat MCH Absorbable Collagen Hemostatic Agent – Fibrillar Form Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Qualification of a heat seal machine.
P810006/S043
6/26/13
CollaStat
Absorbable
Collagen
Hemostatic Sponge.,
CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar Form
Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Proposed replacement of air handling units.
P810031/S048
6/27/13
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV,
and Healon5
Products
Abbott Medical Optics, Inc. 
Santa Ana, CA 92705
Conversion of an existing clean room space into an additional formulation room for the use in the production of the Healon EndoCoat OVD.
P820003/S121
6/6/13
Versatrax, Versatrax IL IPG, Byrel IPG, Symbios LPG, Symbios LPG, Synergyst
IPG, Programmer and Memory Modules, External Pulse Generators, External
Pulse Generator, External Pulse Generator-Dual Chamber, Surgical Cables,
Patient Cables, Adaptor, Disposable Pouch, SEM Printer, Disposable EPG Cover
ECG Cable, Cable
Medtronic, Inc.
Mounds View, MN 55112
Sterilization dose parameter changes for the Models 5846 A and 5846 AL and Models 5846 V and 5846 VL Disposable Patient Cables.
P830061/S094
6/19/13
CapSure Lead, Vitatron Crystaline
Lead, Vitatron Excellence PS+ Lead
Medtronic Inc.
Mounds View MN, 55112
Alternate suppliers for the manufacture of multiple silicone components.
P840001/S240
6/5/13
RestoreAdvanced SureScan MRI and PrimeAdvanced SureScan MRI Implantable
Neurostimulators
Medtronic Neuromodulation
Minneapolis, MN 55432
Changes to in-process visual inspections.
P840062/S026
6/3/13
CollaCote, CollaTape, and CollaPlug – Absorbable Collagen Wound 
Dressing for Dental Surgery
Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Change in bioburden test method and a new testing laboratory.
P840062/S027
6/10/13
CollaCote, CollaTape, and CollaPlug – Absorbable Collagen Wound 
Dressing for Dental Surgery
Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Implementation of Sampling Plan Analyzer software.
P840062/S028
6/18/13
CollaCote, CollaTape, and CollaPlug – Absorbable Collagen Wound 
Dressing for Dental Surgery
Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Changes in cleaning detergent, dirty equipment hold times, and cleaning methods.
P840062/S029
6/20/13
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Implementation of a replacement portable chiller.
P8400062/S030
6/26/13
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Proposed replacement of air handling units.
P850010/S034
6/3/13
Helistat and Helitene – Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Change in bioburden test method and a new testing laboratory.
P850010/S035
6/10/13
Helistat and Helitene – Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Implementation of Sampling Plan Analyzer software.
P850010/S036
6/18/13
Helistat and Helitene – Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Changes in cleaning detergent, dirty equipment hold times, and cleaning methods.
P850010/S037
6/18/13
Helistat and Helitene – Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Change in the Clean Hold Time after the cleaning process of trays.
P850010/S038
6/18/13
Helistat and Helitene – Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Addition of a new freeze dryer.
P850010/S039
6/20/13
Helistat and Helitene – Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Implementation of a replacement portable chiller.
P850010/S040
6/19/13
Helistat and Helitene – Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Proposed modifications to a finished goods acceptance test for collagen and qualification of associated process equipment.
P850010/S041
6/26/13
Helistat and Helitene – Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Proposed replacement of air handling units.
P850089/S099
6/19/13
CapSure SP Novus Lead, CapSure Z Novus Lead, Impulse II Lead Medtronic Inc.
Mounds View MN, 55112
Alternate suppliers for the manufacture of multiple silicone components.
P860057/S109
6/25/13
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic
Bioprosthesis; Carpentier-Edwards PERIMOUNT Magna
Pericardial Aortic Bioprosthesis; Carpentier-Edwards®
PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue
Process; Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral
Bioprosthesis; Carpentier-Edwards PERIMOUNT Magna
Mitral Pericardial Bioprosthesis;  Carpentier-Edwards
PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis
Edwards Lifesciences LLC
Irvine, CA 
92614
Clean room modifications at Edwards’ Irvine Heart Valve Center facility, Tissue Isolation Room, room 153.
P870056/S059
6/25/13
Carpentier-Edwards Porcine Aortic Bioprosthesis, Carpentier-Edwards Porcine Mitral Bioprosthesis, and the Carpentier-
Edwards Bioprosthetic Valved Conduit
Edwards Lifesciences LLC
Irvine, CA 
92614
Clean room modifications at Edwards’ Irvine Heart Valve Center facility, Tissue Isolation Room, room 153.
P870077/S054
6/25/13
Carpentier-Edwards Duraflex Low Pressure Porcine
Mitral Bioprosthesis and the Carpentier-Edwards Duraflex Low Pressure
Mitral Bioprosthesis with Extended Suture Ring
Edwards Lifesciences LLC
Irvine, CA 
92614
Clean room modifications at Edwards’ Irvine Heart Valve Center facility, Tissue Isolation Room, room 153.
P880006/S084
6/6/13
Sensolog/Dialog/ Regency Families St. Jude Medical
Plano, TX 
75024
New Ellipse/Quadra Assura/Fortify Assura implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models: 1) Ellipse VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) Fortify Assura VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC); 3) Ellipse DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC); 4) Fortify Assura DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC); 5) Unify Assura CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); and 6) Quadra Assura CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC) as well as Model 3330 Version 17.1 Software for the Model 3650 Merlin Patient Care System Programmer, Model EX2000 Version 6.5 Software for the Models EX1150 and EX1100 Merlin@Home Transmitters, and Model MN5000 Version 6.5 Software for the Merlin.net System.
P880086/S229
6/6/13
Affinity/Integrity/
Victory/Zephyr/
Accent Families
St. Jude Medical
Plano, TX 
75024
New Ellipse/Quadra Assura/Fortify Assura implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models: 1) Ellipse VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) Fortify Assura VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC); 3) Ellipse DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC); 4) Fortify Assura DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC); 5) Unify Assura CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); and 6) Quadra Assura CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC) as well as Model 3330 Version 17.1 Software for the Model 3650 Merlin Patient Care System Programmer, Model EX2000 Version 6.5 Software for the Models EX1150 and EX1100 Merlin@Home Transmitters, and Model MN5000 Version 6.5 Software for the Merlin.net System.
P890003/S276
6/6/13
Prodigy IPG Medtronic, Inc. 
Mounds View, MN 55112
Removal of swab test for the devices.
P890003/S279
6/27/13
Prodigy Implantable Pulse Generator Medtronic, Inc. 
Mounds View, MN 55112
Modified battery iodine fill stations for selected low power batteries.
P900033/S028
6/3/13
Integra Dermal Regeneration Template Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Change in bioburden test method and a new testing laboratory.
P900033/S029
6/10/13
INTEGRA Artificial Skin Dermal Regeneration Template Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Implementation of Sampling Plan Analyzer software.
P900033/S030
6/26/13
Integra Dermal Regeneration Template Integra LifeSciences Corporation 
Plainsboro, NJ 08536
Proposed replacement of air handling units.
P900056/S122
6/19/13
Rotablator Rotational Atherectomy System Boston Scientific 
Maple Grove, MN 55311
Changes to the equipment used for the pressing, bonding and fiber optic crimping and trimming operations for the RotaLink Advancer and Catheter which are part of the Rotablator Rotational Atherectomy System.
P910023/S309
6/6/13
Ellipse/Fortify Assura Families of ICDs St. Jude Medical, Cardiac Rhythm Management Division
Plano, TX 
75024
New Ellipse/Quadra Assura/Fortify Assura implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models: 1) Ellipse VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) Fortify Assura VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC); 3) Ellipse DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC); 4) Fortify Assura DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC); 5) Unify Assura CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); and 6) Quadra Assura CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC) as well as Model 3330 Version 17.1 Software for the Model 3650 Merlin Patient Care System Programmer, Model EX2000 Version 6.5 Software for the Models EX1150 and EX1100 Merlin@Home Transmitters, and Model MN5000 Version 6.5 Software for the Merlin.net System.
P910023/S315
6/6/13
Ellipse Families of ICDs St. Jude Medical CRMD
Sylmar, CA 
91342
Modifications to the IS-1 Spring Installation procedure, the addition of a visual inspection of the spring, and the addition of an internal threading inspection.
P910023/S316
6/12/13
Fortify, Promote Quadra Family of ICDs St. Jude Medical CRMD
Sylmar CA 
91342
Modification of the hybrid post burn-in ATE testing for the devices.
P910023/S318
6/12/13
Fortify, Fortify Assura, Ellipse Family of ICDs St. Jude Medical CRMD
Sylmar CA 
91342
Modification of AUX converter ATE testing for the devices.
P910023/S319
6/11/13
Current+, Fortify, Fortify Assura, Epic II/Epic II+, Ellipse ICDs St. Jude Medical CRMD
Sylmar, CA 
91342
Addition of a barrier layer for the final finish of hybrid substrates.
P910077/S135
6/20/13
LATITUDE Communicator Boston Scientific Corporation
St. Paul, MN 
55112
Alternate Surface Mount Technology (SMT) line for production of printed circuit board assemblies.
P930031/S043
6/6/13
Wallstent® Endoprosthesis TIPS Boston Scientific Corporation
Maple Grove, MN 55311
Vendor location change.
P930031/S044
6/26/13
Wallstent (Tips) Endoprosthesis with Unistep Plus Delivery System Boston Scientific Corporation
One Scimed Place 
Maple Grove, MN 55311
Change to the braiding inspection process.
P930039/S090
6/19/13
CapSureFix Novus Lead, Vitatron Crystalline Lead Medtronic Inc.
Mounds View MN, 55112
Alternate suppliers for the manufacture of multiple silicone components.
P940015/S027
6/28/13
Synvisc® and Synvisc-One® Synvisc® and Synvisc-One® Genzyme Corporation 
Cambridge, MA 02142
Increase in extract production.
P940019/S037
6/6/13
Wallstent® Endoprosthesis Iliac Boston Scientific Corporation 
Maple Grove, MN 55311
Requested a vendor location change.
P940019/S038
6/26/13
Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System Boston Scientific Corporation
One Scimed Place 
Maple Grove, MN 55311
Change to the braiding inspection process.
P960011/S023
6/4/13
BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) Ferring Pharmaceuticals Incorporated 
Parsippany, NJ 07054
Add a new syringe denester machine and an alternative assembly and labeling machine.
P960028/S037
6/18/13
ReZoom Multifocal IOL Abbott Medical Optics, Inc.
Santa Ana, CA 92705
New test method validation for the Ultra High Performance Liquid Chromatography (UHPLC) System.
P960040/S294
6/6/13
CONFIENT, LIVIAN, INCEPTA, ENERGEN, PUNCTUA,
TELIGEN, VITALITY Families of ICDs
Boston Scientific Corporation
St. Paul, MN 
55112
Alternate sterilization cycle to reduce the evacuation dwell time during the EO removal phase.
P960040/S295
6/21/13
INCEPTA and PUNCTUA ICD Boston Scientific Corporation
St. Paul, MN 
55112
Add two new MOSFET acceptance test cases for the devices.
P970013/S054
6/6/13
Microny Family St. Jude Medical
Plano, TX 
75024
New Ellipse/Quadra Assura/Fortify Assura implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models: 1) Ellipse VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) Fortify Assura VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC); 3) Ellipse DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC); 4) Fortify Assura DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC); 5) Unify Assura CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); and 6) Quadra Assura CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC) as well as Model 3330 Version 17.1 Software for the Model 3650 Merlin Patient Care System Programmer, Model EX2000 Version 6.5 Software for the Models EX1150 and EX1100 Merlin@Home Transmitters, and Model MN5000 Version 6.5 Software for the Merlin.net System.
P980016/S418
6/14/13
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD Medtronic, Inc. 
Mounds View, MN 55112
Use the Chemical Verification Traceability (CTS) system at MTC hybrid manufacturing.
P980016/S419
6/19/13
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD Medtronic Inc.
Mounds View MN, 55112
Alternate suppliers for the manufacture of multiple silicone components.
P980016/S420
6/26/13
Intrinsic ICD, Marquis DR ICD, Marquis VR ICD, Maximo DR ICD, Maximo II
ICD, Maximo
VR ICD, Protecta ICD, Protecta XT ICD, Secura ICD, EnTrust ICD, Virtuoso ICD,
Virtuoso II DR/VR ICD
Medtronic Inc.
Mounds View MN, 55112
Addition of a new press for the pin insertion operation.
P980016/S421
6/24/13
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR
ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD,
Virtuoso II DR/VR ICD
Medtronic Inc.
Mounds View MN, 55112
Updates to the battery laser marking equipment and process.
P980033/S032
6/6/13
Wallstent® Endoprosthesis Venous Boston Scientific Corporation 
Maple Grove, MN 55311
Requested a vendor location change.
P980033/S033
6/26/13
Wallstent (Venous) Endoprosthesis with Unistep Plus Delivery System Boston Scientific Corporation
One Scimed Place 
Maple Grove, MN 55311
Change to the braiding inspection process.
P980035/S324
6/6/13
Adapta, Versa, Sensia IPG Medtronic, Inc. 
Mounds View, MN 55112
Removal of swab test for the devices.
P980035/S328
6/14/13
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG Medtronic, Inc. 
Mounds View, MN 55112
Use the Chemical Verification Traceability (CTS) system at MTC hybrid manufacturing.
P980035/S329
6/19/13
Adapta, Versa, Sensia IPGs,
Relia IPG
Medtronic Inc.
Mounds View MN, 55112
Alternate suppliers for the manufacture of multiple silicone components.
P980035/S330
6/26/13
Advisa DR IPG, EnRhythm IPG,
Sigma DR and Sigma S IPG, Advisa DR MRI
IPG
Medtronic Inc.
Mounds View MN, 55112
Addition of a new press for the pin insertion operation.
P980035/S331
6/27/13
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa, Relia,
Sigma DR, and Sigma S Implantable Pulse Generators
Medtronic, Inc. 
Mounds View, MN 55112
Modified battery iodine fill stations for selected low power batteries.
P980040/S045
6/18/13
SENSAR Acrylic IOL, TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1-Piece IOL Abbott Medical Optics, Inc.
Santa Ana, CA 92705
New test method validation for the Ultra High Performance Liquid Chromatography (UHPLC) System.
P990001/S113
6/26/13
Vitatron C20 SR IPG, Vitatron C60 DR IPG, Vitatron T20 SR IPG, Vitatron T60 DR IPG Medtronic Inc.
Mounds View MN, 55112
Addition of a new press for the pin insertion operation.
P990001/S114
6/27/13
Vitatron C20 SR, Vitatron C60 DR, Vitatron T20 SR, Vitatron
T60 DR implantable pulse generators
Medtronic, Inc. 
Mounds View, MN 55112
Modified battery iodine fill stations for selected low power batteries.
P990038/S018
6/25/13
ETI-MAK-2 PLUS Assay DiaSorin, Inc. 
Stillwater, MN 55082
Change to the Quality Control test method for a component common to all the devices.
P990041/S017
6/25/13
ETI-AB-EBK PLUS Assay DiaSorin, Inc. 
Stillwater, MN 55082
Change to the Quality Control test method for a component common to all the devices.
P990042/S014
6/25/13
ETI-AB-AUK PLUS Assay DiaSorin, Inc. 
Stillwater, MN 55082
Change to the Quality Control test method for a component common to all the devices.
P990043/S018
6/25/13
ETI-EBK PLUS Assay DiaSorin, Inc. 
Stillwater, MN 55082
Change to the Quality Control test method for a component common to all the devices.
P990044/S015
6/25/13
ETI-CORE-IGMK PLUS assay DiaSorin, Inc. 
Stillwater, MN 55082
Change to the Quality Control test method for a component common to all the devices.
P990045/S015
6/25/13
ETI-AB-COREK PLUS assay DiaSorin, Inc. 
Stillwater, MN 55082
Change to the Quality Control test method for a component common to all the devices.
P990074/S026
6/12/13
Natrelle Silicone and Saline-Filled Breast Implants Allergan 
Goleta, CA 
93117
Allergan Costa Rica facility add manufacturing space (floor space) to its production area in the Shell Soaking and Scrubbing Room (Room 2) and Gowning Room (Room 3) and new HEPA filters to Room 2.
P990080/S038
6/18/13
TECNIS Acrylic IOL Abbott Medical Optics, Inc.
Santa Ana, CA 92705
New test method validation for the Ultra High Performance Liquid Chromatography (UHPLC) System.
P000007/S041
6/25/13
Edwards Prima Plus Stentless Porcine Bioprosthesis Edwards Lifesciences LLC
Irvine, CA 
92614
Clean room modifications at Edwards’ Irvine Heart Valve Center facility, Tissue Isolation Room, room 153.
P000012/S041
6/6/13
COBAS® AMPLICOR® Hepatitis C Virus Test and COBAS® AmpliPrep/
COBAS® AMPLICOR® HCV Test
Roche Molecular Systems, Inc. 
Pleasanton, CA 94588
Addition of a new supplier of sub-assemblies used in the production of the COBAS AmpliPrep instrument.
P000012/S042
6/7/13
COBAS® AMPLICOR® Hepatitis C Virus Test and COBAS® AmpliPrep/
COBAS® AMPLICOR® HCV Test
Roche Molecular Systems, Inc. 
Pleasanton, CA 94588
Change to update the specifications for receiving acceptance of a supplier’s material used in the device.
P000012/S043
6/24/13
 COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/
COBAS® AMPLICOR® HCV Test version 2.0
Roche Molecular Systems, Inc. 
Pleasanton, CA 94588
Change to the bulk testing requirements for positive control reagents for both devices.
P010012/S329
6/6/13
INCEPTA, ENERGEN, PUNCTUA, COGNIS, LIVIAN Families of
CRT-Ds
Boston Scientific Corporation
St. Paul, MN 
55112
Alternate sterilization cycle to reduce the evacuation dwell time during the EO removal phase.
P010012/S330
6/21/13
INCEPTA, ENERGEN, PUNCTUA, and 
COGNIS ICDs
Boston Scientific Corporation
St. Paul, MN 
55112
Add two new MOSFET acceptance test cases for the devices.
P010015/S203
6/14/13
Consulta CRT-P, Syncra CRT-P Medtronic, Inc. 
Mounds View, MN 55112
Use the Chemical Verification Traceability (CTS) system at MTC hybrid manufacturing.
P010015/S204
6/19/13
Consulta CRT-P, Syncra CRT-P Medtronic Inc.
Mounds View MN, 55112
Alternate suppliers for the manufacture of multiple silicone components.
P010029/S017
6/4/13
EUFLEXXA (1% sodium hyaluronate) Ferring Pharmaceuticals Incorporated 
Parsippany, NJ 07054
Add a new syringe denester machine and an alternative assembly and labeling machine.
P010031/S378
6/14/13
Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic, Inc. 
Mounds View, MN 55112
Use the Chemical Verification Traceability (CTS) system at MTC hybrid manufacturing.
P010031/S379
6/19/13
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic Inc.
Mounds View MN, 55112
Alternate suppliers for the manufacture of multiple silicone components.
P010031/S380
6/26/13
Concerto ICD, Concerto II CRT-D, Consulta ICD, InSync III
Marquis ICD, InSync Maximo ICD, Maximo
II CRT-D, Protecta CRT-D, Protecta XT CRT-D
Medtronic Inc.
Mounds View MN, 55112
Addition of a new press for the pin insertion operation.
P010031/S382
6/24/13
Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D,
Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRTD
Medtronic Inc.
Mounds View MN, 55112
Updates to the battery laser marking equipment and process.
P010041/S043
6/25/13
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis Edwards Lifesciences LLC
Irvine, CA 
92614
Clean room modifications at Edwards’ Irvine Heart Valve Center facility, Tissue Isolation Room, room 153.
P020004/S082
6/21/13
GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore and Associates
Flagstaff, AZ 
86001
New, automated, pre-lamination wrapper machine.
P020045/S047
6/6/13
Freezor Cardiac CryoAblation Catheter,
Freezor Xtra Surgical Cardiac CryoAblation Device,
Freezor Max Surgical Cardiac CryoAblation Device
Medtronic CryoCath
Mounds View, MN 55112
Implementation of a semi-automated Strip Crimper for the wires in the cable.
P020045/S048
6/21/13
Freezor Cardiac CryoAblation Catheter,
Freezor Xtra Surgical Cardiac CryoAblation Device,
Freezor Max Surgical Cardiac CryoAblation Device
Medtronic AF Solutions
Mounds View, MN 55112
Implementation of a new test apparatus for incoming inspection of the Automatic Switch Connection Box component.
P020056/S020
6/12/13
Natrelle Silicone and Saline-Filled Breast Implants Allergan 
Goleta, CA 
93117
Allergan Costa Rica facility add manufacturing space (floor space) to its production area in the Shell Soaking and Scrubbing Room (Room 2) and Gowning Room (Room 3) and new HEPA filters to Room 2.
P020056/S021
6/20/13
Natrelle Silicone-Filled Breast Implants Allergan 
Goleta, CA 
93117
Additional dry heat sterilizers for processing silicone-filled breast implants.
P030005/S098
6/6/13
CONTAK RENEWAL TR INVIVE Families of CRT-Ps Boston Scientific Corporation
St. Paul, MN 
55112
Alternate sterilization cycle to reduce the evacuation dwell time during the EO removal phase.
P030017/S163
6/4/13
Precision and Precision Spectra Spinal Cord Stimulator Systems Boston Scientific Corporation 
Valencia, CA
91355
Add an alternate welder for use in the manufacturing process.
P030017/S164
6/4/13
Precision and Precision Spectra Spinal Cord Stimulator Systems Boston Scientific Corporation 
Valencia, CA
91355
Move being made by the tubing supplier.
P030017/S165
6/19/13
Precision Spectra Spinal Cord Stimulator System Boston Scientific Corporation 
Valencia, CA
91355
Update the test software for the remote control.
P030017/S166
6/19/13
Precision and Precision Spectra Spinal Cord Stimulator Systems Boston Scientific Corporation 
Valencia, CA
91355
Change the sterilization method.
P030017/S167
6/20/13
Precision Spinal Cord Stimulator System Boston Scientific Corporation 
Valencia, CA
91355
Utilize an alternate welding system for use in the manufacturing process.
P030035/S107
6/6/13
Frontier/Frontier II/Anthem Families St. Jude Medical
Plano, TX 
75024
New Ellipse/Quadra Assura/Fortify Assura implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models: 1) Ellipse VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) Fortify Assura VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC); 3) Ellipse DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC); 4) Fortify Assura DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC); 5) Unify Assura CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); and 6) Quadra Assura CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC) as well as Model 3330 Version 17.1 Software for the Model 3650 Merlin Patient Care System Programmer, Model EX2000 Version 6.5 Software for the Models EX1150 and EX1100 Merlin@Home Transmitters, and Model MN5000 Version 6.5 Software for the Merlin.net System.
P030036/S059
6/19/13
Lead Anchoring Sleeve Kit Medtronic Inc.
Mounds View MN, 55112
Alternate suppliers for the manufacture of multiple silicone components.
P030054/S238
6/6/13
Quadra Assura/Unify Assura Families St. Jude Medical
Plano, TX 
75024
New Ellipse/Quadra Assura/Fortify Assura implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models: 1) Ellipse VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) Fortify Assura VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC); 3) Ellipse DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC); 4) Fortify Assura DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC); 5) Unify Assura CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); and 6) Quadra Assura CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC) as well as Model 3330 Version 17.1 Software for the Model 3650 Merlin Patient Care System Programmer, Model EX2000 Version 6.5 Software for the Models EX1150 and EX1100 Merlin@Home Transmitters, and Model MN5000 Version 6.5 Software for the Merlin.net System.
P030054/S248
6/12/13
Unify, Unify Quadra Family of CRT-Ds St. Jude Medical CRMD
Sylmar CA 
91342
Modification of the hybrid post burn-in ATE testing for the devices.
P030054/S250
6/12/13
Unify, Unify Assura, Quadra Assura Family of CRT-Ds St. Jude Medical CRMD
Sylmar CA 
91342
Modification of AUX converter ATE testing for the devices.
P030054/S251
6/11/13
Promote+, Unify, Unify Quadra, Quadra Assura CRT-Ds St. Jude Medical CRMD
Sylmar, CA 
91342
Addition of a barrier layer for the final finish of hybrid substrates.
P040037/S051
6/4/13
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with
Heparin Bioactive Surface
W.L. Gore and Associates, Inc.
Flagstaff, AZ 
86001
Change the in-process component inspection acceptance criteria for the outer layer zipper coverage in the deployment system for the VIABAHN devices.
P040037/S052
6/14/13
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface W.L. Gore and Associates, Inc.
Flagstaff, AZ 
86001
Change the pressure parameter for the package sealing equipment for the device.
P040037/S053
6/17/13
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface W.L. Gore and Associates, Inc.
Flagstaff, AZ 
86001
Add an alternate supplier for raw Heparin Sodium.
P040038/S029
6/11/13
Xact Carotid Stent System Abbott Vascular
Temecula, CA 92591
Change to the pyrogen sampling plan.
P040043/S053
6/21/13
GORE® TAG® Thoracic Endoprosthesis W.L. Gore and Associates
Flagstaff, AZ 
86001
New, automated, pre-lamination wrapper machine.
P040046/S002
6/12/13
Natrelle Silicone and Saline-Filled Breast Implants Allergan 
Goleta, CA 
93117
Allergan Costa Rica facility add manufacturing space (floor space) to its production area in the Shell Soaking and Scrubbing Room (Room 2) and Gowning Room (Room 3) and new HEPA filters to Room 2.
P040046/S003
6/20/13
Natrelle Silicone-Filled Breast Implants Allergan 
Goleta, CA 
93117
Additional dry heat sterilizers for processing silicone-filled breast implants.
P040047/S026
6/7/13
Coaptite Injectable Implant Merz Aesthetics, Inc. 
Franksville, WI 53126
Addition of a new supplier for a Critical Component of the device.
P050019/S014
6/26/13
Carotid Wallstent Monorail Endoprosthesis Boston Scientific Corporation
Maple Grove, MN 55311
Change to the braiding inspection process.
P050028/S032
6/6/13
COBAS® TaqMan HBV Test For Use with the High Pure System and 
COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Inc. 
Pleasanton, CA 94588
Addition of a new supplier of sub-assemblies used in the production of the COBAS AmpliPrep instrument.
P050028/S033
6/24/13
COBAS® TaqMan HBV Test For Use With The High Pure System and 
COBAS® AmpliPrep/COBAS® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Inc. 
Pleasanton, CA 94588
Change to the bulk testing requirements for positive control reagents for both devices.
P050038/S018
6/18/13
ARISTA AH Absorbable Hemostat Medafor Inc. 
Hemostatic Polymer Technologies 
Minneapolis, MN 55430
Change in packaging process.
P060006/S046
6/21/13
Express SD Renal Premounted Stent System Boston Scientific
Maple Grove, MN 55311
Software modifications to the balloon stretching process.
P060030/S032
6/6/13
 COBAS® AmpliPrep/COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use with The High Pure System Roche Molecular Systems, Inc. 
Pleasanton, CA 94588
Addition of a new supplier of sub-assemblies used in the production of the COBAS AmpliPrep instrument.
P060037/S022
6/21/13
NexGen® LPS/LPS-Mobile Bearing Knee Zimmer, Inc.
Warsaw, IN
46581
Change to the CNC machine coolant.
P060040/S027
6/3/13
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA 94588
Addition of an alternate burn-in fixture for use during the manufacturing of the HeartMate LVAS pumps.
P070015/S110
6/11/13
XIENCE V and XIENCE Nano Everolimus Eluting Coronary Stent
Systems
Abbott Vascular
Temecula, CA 92591
Change to the pyrogen sampling plan.
P070015/S112
6/27/13
XIENCE V® Everolimus-Eluting Coronary Stent System (RX and OTW) Abbott Vascular
Temecula, CA 92591
Change the APHA color test method for a solvent used in the manufacturing of AV’s device-drug combination products.
P080006/S055
6/19/13
Attain Ability Lead Medtronic Inc.
Mounds View MN, 55112
Alternate suppliers for the manufacture of multiple silicone components.
P080010/S009
6/18/13
TECNIS Multifocal 3-Piece IOL Abbott Medical Optics, Inc.
Santa Ana, CA 92705
New test method validation for the Ultra High Performance Liquid Chromatography (UHPLC) System.
P080012/S018
6/24/13
Prometra Programmable Infusion Pump System Flowonix Medical, Inc.
Mount Olive, NJ 
07828
Alternate supplier for the Prometra Programmable Infusion Pump.
P080030/S009
6/20/13
iStent Trabecular Micro-Bypass Stent System Glaukos Corporation 
Laguna Hills, CA 92653
Add an alternate qualified supplier of stearalkonium heparin
P090013/S100
6/14/13
Revo MRI IPG Medtronic, Inc. 
Mounds View, MN 55112
Use the Chemical Verification Traceability (CTS) system at MTC hybrid manufacturing.
P090013/S102
6/26/13
Revo MRI IPG Medtronic Inc.
Mounds View MN, 55112
Addition of a new press for the pin insertion operation.
P090018/S021
6/25/13
Esteem System Envoy Medical Corporation 
Saint Paul, MN 55110
Changes to the lead manufacturing process.
P100010/S027
6/6/13
Freezor Max Cardiac CryoAblation Device Medtronic CryoCath
Mounds View, MN 55112
Implementation of a semi-automated Strip Crimper for the wires in the cable.
P100010/S028
6/12/13
Arctic Front CryoAblation Catheter, Arctic Front Advance CryoAblation Catheter Medtronic AF Solutions
Mounds View, MN 55112
Acceptance for the resequencing of manufacturing steps used in the manufacture of the Arctic Front and Arctic Front Advance catheters.
P100021/S026
6/25/13
Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Change to the water soluble additive that is used during the laser cutting process.
P100034/S005
6/12/13
NovoTTF-100A System Novocure Ltd.
Haifa, Israel 
31905
Manufacturing change to the INE transducer array cable and flexible printed circuit board (PCB) of the device.
P100041/S029
6/25/13
Edwards SAPIEN™ Transcatheter Heart Valve Edwards Lifesciences LLC
Irvine, CA 
92614
Changing the silicone gasket material (supplied by Saint Gobain) for the 3.8 oz. jar cap gasket used in the finished-device packaging container for the Edwards SAPIEN valve.
P100041/S030
6/25/13
Edwards SAPIEN™ Transcatheter Heart Valve Edwards Lifesciences LLC
Irvine, CA 
92614
Clean room modifications at Edwards’ Irvine Heart Valve Center facility, Tissue Isolation Room, room 153.
P100046/S002
6/14/13
AtriCure Synergy Ablation System Atricure Inc. 
West Chester, OH 45069
Addition of a visual inspection for proximal weld length for the devices, modifications relating to the Laser Welder for distal and proximal jaw weldments and the addition of a re-welding process for the OLL2 and OSL2 proximal and distal weldments.
P110007/S005
6/27/13
AMO Healon EndoCoat Ophthalmic Viscosurgical Device (OVD), 
(3% Sodium Hyaluronate)
Abbott Medical Optics, Inc. 
Santa Ana, CA 92705
Conversion of an existing clean room space into an additional formulation room for the use in the production of the Healon EndoCoat OVD.
P110019/S046
6/11/13
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary
Stent Systems
Abbott Vascular
Temecula, CA 92591
Change to the pyrogen sampling plan.
P110019/S049
6/27/13
XIENCE PRIME® and XIENCE PRIME Long Lengths Everolimus-Eluting Coronary
Stent Systems (RX),
XIENCE XPEDITION™, XIENCE XPEDITION Small Vessel and XIENCE
XPEDITION Long Lengths Everolimus-Eluting Coronary Stent Systems (RX and OTW)
Abbott Vascular
Temecula, CA 92591
Change the APHA color test method for a solvent used in the manufacturing of AV’s device-drug combination products.
P110021/S015
6/25/13
Edwards SAPIEN™ Transcatheter Heart Valve Edwards Lifesciences LLC
Irvine, CA 
92614
Changing the silicone gasket material (supplied by Saint Gobain) for the 3.8 oz. jar cap gasket used in the finished-device packaging container for the Edwards SAPIEN valve.
P110021/S016
6/25/13
Edwards SAPIEN™ Transcatheter Heart Valve Edwards Lifesciences LLC
Irvine, CA 
92614
Clean room modifications at Edwards’ Irvine Heart Valve Center facility, Tissue Isolation Room, room 153.
P110028/S008
6/26/13
Absolute Pro® Vascular Self-Expanding Stent System Abbott Vascular, Inc.
Temecula, CA 92591
Add a vendor of the stent marker tabs.
P110032/S003
6/13/13
Aorfix™ AAA Flexible Stent Graft System Lombard Medical Technologies, Inc.
Tempe, AZ 
85284
Modified sterilization cycle.
P110035/S014
6/6/13
Epic™ Vascular Self-Expanding Stent System Boston Scientific Corporation 
Maple Grove, MN 55311
Vendor location change.
P110037/S006
6/6/13
COBAS® AmpliPrep/COBAS® TaqMan® CMV Test Roche Molecular Systems, Inc. 
Pleasanton, CA 94588
Addition of a new supplier of sub-assemblies used in the production of the COBAS AmpliPrep instrument.
P120005/S006
6/28/13
Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom, Inc. 
San Diego, CA 92121
Change to the semi-automated assembly equipment for three sub-assemblies (cannula, pushrod carrier, and needle carrier).
P120008/S003
6/12/13
ARCHITECT AFP Abbott Laboratories 
Abbott Park, IL 60064
Change for the addition of a quality control test for protein purity of incoming raw material (Albumin Bovine 30% Solution with 0.1% Sodium Azide (bovine albumin solution) used in the manufacturing of controls and calibrators for the Architect AFP assay. Due to the raw material distributor not having a validated quality control test for protein purity, the additional quality control test will be implemented to ensure the protein purity of the raw material meets the manufacturer’s specifications.

 

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