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. |
