Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 92
Summary of PMA Originals Under Review
Total Under Review: 49
Total Active: 18
Total On Hold: 31
Summary of PMA Supplements Under Review
Total Under Review: 640
Total Active: 480
Total On Hold: 160
Summary of All PMA Submissions Received
Originals: 3
Supplements: 82
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 92
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 140
FDA Time: 98.7 Days MFR Time: 41.3 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P100022 11/14/12 |
Zilver PTX Drug-Eluting Peripheral Stent (6- 8 mm diameter; 20- 80 mm length) | Cook Incorporated Bloomington, IN 47402 |
Approval for the Zilver PTX Drug-Eluting Peripheral Stent. This device is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameters from 4 mm to 9 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient. |
P100047 11/20/12 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Approval for the HeartWare® Ventricular Assist System (VAS). This device is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The Heart Ware® VAS is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter. |
P120002 11/7/12 |
S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent Systems | Cordis Corporation Miami Lakes, FL 33014 |
Approval for the S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent Systems. This device is indicated for use to improve luminal diameter in the treatment of patients with de novo or restenotic native lesion(s) of the superficial femoral artery and/or proximal popliteal artery with total length up to 150 mm and with a reference vessel diameter ranging from 4 mm to 7 mm. |
P120008 11/28/12 |
ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls | Abbott Laboratories Abbott Park, IL 60064 |
Approval for the ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls. This device is indicated for: The ARCHITECT AFP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of alpha-fetoprotein (AFP) in: 1) Human serum or plasma to aid in monitoring disease progression during the course of disease and treatment of patients with nonseminomatous testicular cancer; and 2) Human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of fetal open neural tube defects (NTD). Test results when used in conjunction with ultrasonography or amniography are a safe and effective aid in the detection of fetal open NTD. The ARCHITECT AFP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of alpha-fetoprotein (AFP) in human serum, plasma, and amniotic fluid. The performance of the ARCHITECT AFP Calibrators has not been established with any other AFP assays. The ARCHITECT AFP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of alpha-fetoprotein (AFP) in human serum, plasma, and amniotic fluid. The performance of the ARCHITECT AFP controls has not been established with any other AFP assays. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P810002/S078 11/1/12 Real-Time |
SJM Regent Mechanical Heart Valve, Mechanical Heart Valve SJM Masters Series (PTFE), Mechanical Heart Valve SJM Masters Series (Polyester) Mechanical HV SJM Masters Series Coated Aortic Valve Graft, SJM Masters HP Valved Graft w/Gelweave Valsalva Tech | St. Jude Medical St. Paul, MN 55117 |
Approval to update the Instructions for Use (IFU), St. Jude Medical (SJM) internet, and any other applicable device labeling to include the new magnetic resonance imaging (MRI) testing information to enhance the safe use of the device when undergoing MRI. |
P830055/S127 11/19/12 Real-Time |
LCS® Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for the addition of mobile bearing Attune PS RP tibial inserts that are modifications to the previously approved LCS Complete/PFC Sigma RP/Attune RP tibial inserts, and are intended to be used with the cleared Attune Total Knee System femoral, patella, and components. The supplement also requests the addition of a 9mm tibial insert thickness for all sizes (I – I 0) of Attune CR RP tibial inserts. The new inserts are manufactured from the antioxidant polyethylene material (AOX™). The device, as modified, will be marketed under the trade name Attune™ and is indicated for use in total knee replacement in patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. |
P830055/S128 11/19/12 Special |
LCS® Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for an additional rinse step being implemented in the manufacturing process for the MBT Cemented and Porous Trays and the Attune RP Tibial Base. |
P850048/S028 11/19/12 Special |
Access Hybritech PSA reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of information to the Manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification.) |
P860003/S066 11/9/12 Real-Time |
THERAKOS® UVAR XTS® Photopheresis System Procedural Kit | THERAKOS, Inc. Raritan, NJ 08869 |
Approval for the addition of 8 ribs to the neck of the centrifuge bowls used in the device and for the accompanying packaging changes. |
P860003/S067 11/19/12 Real-Time |
THERAKOS® CELLEX® Photopheresis System | THERAKOS, Inc. Raritan, NJ 08869 |
Approval for some minor changes intended to reduce specular reflection of the KT8L sensor’s laser beam and improve its optic path (e.g., removal of glass port, removal of resistor, and addition of gasket). |
P880006/S082 11/7/12 Real-Time |
Sensolog, Dialog and Regency Family of Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Approval for software changes to the Merlin PCS Programmer. |
P880086/S223 11/7/12 Real-Time |
Affinity, Integrity, Victory, Zephyr, and Accent Family of Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Approval for software changes to the Merlin PCS Programmer. |
P900060/S050 11/5/12 135-Day |
Carbomedics Prosthetic Heart Valve | Sorin Group USA, Inc. Arvada, CO 80004 |
Approval for addition of an alternate supplier for manufacturing of the graphite substrate of valve leaflets. |
P910023/S302 11/7/12 Real-Time |
Cadence and Current Family of ICDs | St. Jude Medical Sylmar, CA 91342 |
Approval for software changes to the Merlin PCS Programmer. |
P930027/S015 11/8/12 135-Day |
IMMULITE PSA Assay | Siemens Medical Solutions Diagnostics East Walpole, MA 02032 |
Approval for eliminating the test redundancy by using only the BioRad Lyphocheck Immunoassay Plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of IMMULITE AFP, Free PSA, and PSA/3 rd Generation PSA assay performance. |
P950024/S040 11/27/12 180-Day |
CapSure Epi Epicardial Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval to add Model 4965 post-approval study results to the device labeling. |
P950024/S044 11/27/12 180-Day |
CapSure Epi Epicardial Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval to add Model 4968 post-approval study results to the device labeling. |
P950032/S069 11/20/12 Real-Time |
Apligraf (Graftskin) | Organogenesis, Incorporated Canton, MA 02021 |
Approval for the introduction of Human Epidermal Keratinocyte cell strain 200 (HEP 200) into the manufacture of the device. |
P960040/S266 11/14/12 135-Day |
Incepta, Energen, Punctua, Teligen, Confient ICDs |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of an automated vision system during seal plug inspection. |
P960040/S270 11/30/12 180-Day |
Incepta, Energen, Punctua and Teligen Implantable Cardioverter Defibrillator | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for software, firmware, and hardware enhancements and modifications to the INCEPTA, ENERGEN, PUNCTUA, COGNIS, and TELIGEN devices. |
D970003/S137 11/14/12 135-Day |
Advantio, Ingenio, Altrua Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of an automated vision system during seal plug inspection. |
P970004/S141 11/1/12 180-Day |
Interstim Therapy | Medtronic Vascular Minneapolis, MN 55432 |
Approval for the post-approval study protocol. |
P970013/S051 11/7/12 Real-Time |
Microny Family of Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Approval for software changes to the Merlin PCS Programmer. |
P970018/S025 11/8/12 135-Day |
BD PrepStain System | TriPath Imaging Durham, NC 27703 |
Approval for a supplier change to the raw microsope slide, a critical component in the device. |
P970038/S017 11/19/12 Special |
Access Hybritech Free reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of information to the Manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification.) |
P970051/S097 11/9/12 Real-Time |
Nucleus® Cochlear™ Implant System | Cochlear Americas Centennial, CO 80111 |
Approval to introduce a remote control (CR120) for use with the Nucleus 5 (model CP810) sound processor for intraoperative use to conduct impedance and AutoNRT, measurements that are commonly used during cochlear implant surgery to indicate that the electrodes are functioning and are stimulating nerve tissue. |
P980016/S384 11/2/12 Real-Time |
Entrust, Intrinsic, Marquis, Onyx, Secura, Gem, Maximo, Protecta and Virtuoso | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an update to the raw material of the capacitors used in the high voltage delivery circuitry. |
P980022/S124 11/16/12 Real-Time |
iPro2 Continuous Glucose Monitoring (COM) System | Medtronic MiniMed Northridge, CA 91325 |
Approval for software modifications to the CareLink iPro Therapy Management Software (MMT-7340) from version 1.4 to version 1.5A. The CareLink iPro Therapy Management Software (MMT-7340) is a component of the iPro2 Professional CGM System (MMT-7745). |
P980041/S018 11/19/12 Special |
Access Hybritech AFP reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of information to the Manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification.) |
P990038/S017 11/30/12 Special |
ETI-MAK-2 PLUS Assay | DiaSorin, Inc. Stillwater, MN 55082 |
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates. |
P990041/S016 11/30/12 Special |
ETI-AB-EBK Assay | DiaSorin, Inc. Stillwater, MN 55082 |
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates. |
P990042/S013 11/30/12 Special |
ETI-AB-AUK Plus Assay | DiaSorin, Inc. Stillwater, MN 55082 |
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates. |
P990043/S017 11/30/12 Special |
ETI-EBK PLUS Assay | DiaSorin, Inc. Stillwater, MN 55082 |
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates. |
P990044/S014 11/30/12 Special |
ETI-CORE-IGMK PLUS Assay | DiaSorin, Inc. Stillwater, MN 55082 |
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates. |
P990045/S014 11/30/12 Special |
ETI-AB-COREK PLUS Assay | DiaSorin, Inc. Stillwater, MN 55082 |
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates. |
P990071/S020 11/20/12 Real-Time |
CoolFlow Irrigation Pump | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for software and hardware modifications implemented to make the device compliant to IEC 60601-1 3 rd Edition. |
P990081/S014 11/14/12 Real-Time |
PATHWAY Anti-HER-2/neu ( 4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for implementing a change to the Ventana regent dispenser seal for the Benchmark automated staining instruments. |
P000008/S029 11/9/12 180-Day |
LAP-BAND Adjustable Gastric Banding (LAGB) System | Allergan, Inc. Goleta, CA 93117 |
Approval of the post-approval study protocol. |
P000013/S011 11/2/12 180-Day |
Trident Ceramic-on-Ceramic Acetabular System | Howmedica Osteonics Corporation Mahwah, NJ 07430 |
Approval for labeling updates incorporating results of the completed post-approval study. |
P000025/S058 11/21/12 180-Day |
MED-EL COMBI 40+ Cochlear Implant System and Mi1000 MED-EL CONCERT PIN Cochlear Implant. |
MED-EL Corporation Durham, NC 27713 |
Approval for the Mi1000 MED-EL CONCERT PIN cochlear implant. |
P000025/S064 11/1/12 Real-Time |
MED-EL COMBI 40+ Cochlear Implant System, MED-EL CONCERT Implant |
MED-EL Corporation Durham, NC 27713 |
Approval for a minor design change to the stimulator housing component of the Mi1000 MED-EL CONCERT implant that is intended to correct an error of dimensional tolerance of the housing components used in the manufacturing of the devices. |
P000053/S046 11/13/12 Real-Time |
AMS 800™ Urinary Control System | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for minor design change to the Pump Shell Interface tolerances. |
P010007/S009 11/8/12 135-Day |
IMMULITE AFP Assay | Siemens Medical Solutions Diagnostics East Walpole, MA 02032 |
Approval for eliminating the test redundancy by using only the BioRad Lyphocheck Immunoassay Plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of IMMULITE AFP, Free PSA, and PSA/3 rd Generation PSA assay performance. |
P010012/S296 11/14/12 135-Day |
Incepta, Energen, Punctua, Cognis, Livian CRT-Ds |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of an automated vision system during seal plug inspection. |
P010012/S300 11/30/12 180-Day |
Incepta, Energen, Punctua and Cognis Cardiac Resynchronization Therapy-Defibrillator | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for software, firmware, and hardware enhancements and modifications to the INCEPTA, ENERGEN, PUNCTUA, COGNIS, and TELIGEN devices. |
P010013/S045 11/15/12 Real-Time |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Malborough, MA 01752 |
Approval for a change to fittings in the suction and vacuum feedback lines and minor labeling changes. |
P010030/S031 11/2/12 180-Day |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval for several hardware design changes and a software driver upate. |
P010031/S336 11/2/12 Real-Time |
Consulta, Maximo II, Concerto and Insync | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an update to the raw material of the capacitors used in the high voltage delivery circuitry. |
P010033/S020 11/15/12 180-Day |
QuantiFERON® Gold In-Tube | Cellestis Incorporated Valencia, CA 91355 |
Approval for a change in the formulation of the Wash Buffer 20X Concentrate. |
P010038/S016 11/9/12 180-Day |
SecondLook DigitalV7.2 CAD | iCAD, Inc. Nashua, NH 03062 |
Approval for the SecondLook Digital V7.2 CAD for use with the Philips MicroDose full-field digital mammography (FFDM) system. |
P020004/S072 11/7/12 135-Day |
GORE EXCLUDER AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for use of an alternate PTFE resin. |
P020004/S074 11/20/12 180-Day |
GORE® EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Phoenix, AZ 85085 |
Approval for the additions of the 35 mm Trunk-Ipsilateral Leg and 36 mm Aortic Extender components to the GORE EXCLUDER AAA Endoprosthesis product portfolio. |
P020004/S075 11/20/12 Real-Time |
GORE® EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Phoenix, AZ 85085 |
Approval for the modification of the delivery system for the following device components of the GORE EXCLUDER AAA Endoprosthesis on the SIM-PULL (original) and C3 (EMDS) catheters in order to lower their delivery profiles as outlined below: 1) 16, 18 and 20 mm Contralateral Legs from 18 Fr to 12 Fr; 2) 23 mm Contralateral Leg from 18 Fr to 14 Fr; 3) 27 mm Colateral Leg from 18 Fr to 15 Fr; 4) 23, 26, 28.5 mm Aortic Extenders from 18 Fr to 16 Fr; 5) 32 mm Aortic Extender from 20 Fr to 17 Fr; 6) 31 mm Trunk-Ipsilateral Leg with SIM-PULL delivery system from 20 Fr to 18 Fr; and 7) 31 mm Trunk-Ipsilateral Leg with C3 delivery system from 20 Fr to 18 Fr. |
P020055/S004 11/14/12 Real-Time |
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for implementing a change to the Ventana regent dispenser seal for the Benchmark automated staining instruments. |
P030005/S085 11/14/12 135-Day |
Invive CRT-Ps | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the addition of an automated vision system during seal plug inspection. |
P030017/S144 11/16/12 Real-Time |
Implantable Pulse Generator (IPG) | Boston Scientific Neuromodulation (BSN) Valencia, CA 91355 |
Approval for a material change or the Implantable Pulse Generator (IPG) antenna coil from gold to copper. |
P030017/S145 11/19/12 Real-Time |
Precision Spinal Cord Stimulator (SCS) | Boston Scientific Neuromodulation (BSN) Valencia, CA 91355 |
Approval for an update to the Clinician Programmer computer used with the device. A tablet computer from ASUS, model EEE Slate B121, will be used to replace the current Clinician Programmer (CP), a Toshiba model M400 laptop computer. |
P030035/S101 11/7/12 Real-Time |
Frontier, Frontier II, and Anthem Family of CRT-Ps | St. Jude Medical Sylmar, CA 91342 |
Approval for software changes to the Merlin PCS Programmer. |
P030036/S040 11/2/12 180-Day |
SelectSecure Lead | Medtronic CRDM Mounds View, MN 55112 |
Approval for improvements to the SelectSecure Model 3830 lead drug methods and specifications. |
P030052/S010 11/13/12 Special |
UroVysion Bladder Cancer Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for labeling changes to the UroVysion Bladder Cancer Kit package insert, kit and vial labeling. |
P030054/S230 11/7/12 Real-Time |
Epic HF, Atlas+ HF, and Promote Family of CRT-Ds | St. Jude Medical Sylmar, CA 91342 |
Approval for software changes to the Merlin PCS Programmer. |
P040011/S002 11/2/12 180-Day |
c-Kit pharmDx™ | Dako North America, Inc. Carpinteria, CA 93013 |
Approval for changing the company prefix to the device name (from Dako-Cytomation c-Kit pharmDx™ to c-Kit pharmDx™). The device, as modified, will be marketed under the trade name c-Kit pharmDx™. |
P040016/S093 11/5/12 135-Day |
VeriFLEX(Liberte) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for use of an alternate cleaning procedure. |
P040021/S020 11/1/12 Real-Time |
SJM Epic Valve SJM Biocor Valve |
St. Jude Medical St. Paul, MN 55117 |
Approval to update the Instructions for Use (IFU), St. Jude Medical (SJM) internet, and any other applicable device labeling to include the new magnetic resonance imaging (MRI) testing information to enhance the safe use of the device when undergoing MRI. |
P040043/S047 11/7/12 135-Day |
GORE TAG THORACIC Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for use of an alternate PTFE resin. |
P050006/S029 11/26/12 135-Day |
GORE HELEX Septal Occluder | W. L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for use of new testing equipment. |
P050037/S023 11/6/12 135-Day |
Radiesse Injectable Implant | Merz Aesthetics, Inc. Franksville, WI 53126 |
Approval for addition of new clean suites to existing clean room facility. |
P050037/S032 11/8/12 135-Day |
Radiesse Injectable Implant | Merz Aesthetics, Inc. Franksville, WI 53126 |
Approval for a change to syringe assembly. |
P050048/S007 11/13/12 135-Day |
MONOLISA™ Anti-HBs EIA and MONOLISA™ Anti-HBs Calibrator Kit | Bio-Rad Laboratories, Inc. Redmond, WA 98052 |
Approval for the modification of the quality control testing specification for the 400 mIU/mL Calibrator in the device. |
P050052/S026 11/6/12 135-Day |
Radiesse Injectable Implant | Merz Aesthetics, Inc. Franksville, WI 53126 |
Approval for addition of new clean suites to existing clean room facility. |
P050052/S035 11/8/12 135-Day |
Radiesse Injectable Implant | Merz Aesthetics, Inc. Franksville, WI 53126 |
Approval for a change to syringe assembly. |
P060005/S008 11/8/12 135-Day |
IMMULITE FPSA Assay | Siemens Medical Solutions Diagnostics East Walpole, MA 02032 |
Approval for eliminating the test redundancy by using only the BioRad Lyphocheck Immunoassay Plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of IMMULITE AFP, Free PSA, and PSA/3 rd Generation PSA assay performance. |
P060006/S031 11/5/12 135-Day |
Express SD Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for use of an alternate cleaning procedure. |
P060008/S093 11/5/12 135-Day |
TAXUS Liberte Paciltaxel-eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for use of an alternate cleaning procedure. |
P060019/S023 11/29/12 135-Day |
Safire BLU and Therapy Cool Path Bi-Directional Ablation Catheters | St. Jude Medical Irvine, CA 92614 |
Approval for an alternate supplier of the catheter shaft subassembly. |
P060023/S003 11/30/12 135-Day |
Bryan Cervical Disc | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for a revision to the bioburden enumeration test frequency for ethylene oxide. |
P070016/S005 11/5/12 135-Day |
Zenith TX2 TAA Endovascular Graft | Cook Incorporated Bloomington, IN 47402 |
Approval for in-house manufacture of stent graft material. |
P070026/S008 11/21/12 Real-Time |
DePuy Ceramax Ceramic Total Hip System | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Approval for addition of Summit Porocoat Stems as a compatible component to existing 28 mm ceramic head. |
P070026/S009 11/21/12 Real-Time |
DePuy Ceramax Ceramic Total Hip System | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Approval for addition of Pinnacle 300, Multi-hole II and Sector II acetabular cup components. |
P080011/S018 11/1/12 180-Day |
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses | CooperVision, Incorporated Pleasanton, CA 94588 |
Approval for a manufacturing site located at CooperVision Caribbean Corporation in Juana Diaz, Puerto Rico. |
P080030/S001 11/15/12 135-Day |
Glaukos Corporation iStent Trabecular Micro-Bypass Stent System | Glaukos Corporation Laguna Hills, CA 92653 |
Approval of the shelf-life extension for two lots of Duraflo coating material used in the device. |
P080030/S002 11/8/12 135-Day |
Glaukos Corporation iStent Trabecular Micro-Bypass Stent System | Glaukos Corporation Laguna Hills, CA 92653 |
Modifications to the design of the outer blister tray used for device packaging. |
P080032/S010 11/9/12 Special |
Alair Bronchial Thermoplasty System | Boston Scientific Corporation Sunnyvale, CA 94089 |
Approval for labeling changes to the Alair Catheter Model ATS 2-5 Directions For Use (DFU), Alair Radiofrequency (RF) Controller Model ATS 200 Operator’s Manual, and Alair Bronchial Thermoplasty System Patient Brochure. |
P090003/S014 11/5/12 135-Day |
Express LD Monorail Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for use of an alternate cleaning procedure. |
P090018/S011 11/13/12 135-Day |
Esteem | Envoy Medical Corporation Saint Paul, MN 55110 |
Approval for the EO Sterilization load configuration change for the Esteem product family. |
P090026/S001 11/19/12 Special |
Access Hybritech Free p2PSA reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of information to the Manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification.) |
P100020/S005 11/19/12 Real-Time |
cobas® HPV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94558 |
Approval for changes to the CPU component of the cobas® z480 Analyzer. |
P100024/S003 11/27/12 Real-Time |
HER2 CISH pharmDx™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for a change in the mounting medium reagent supplied in the kit. |
P100025/S003 11/6/12 Special |
BreathTek® UBT forH. pylori Kit | Otsuka Product Development & Commercialization, Inc. Rockville, MD 20850 |
Approval for a labeling change to enhance the safe use of the device. |
P100027/S003 11/14/12 Real-Time |
INFORM HER-2 DUAL ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for implementing a change to the Ventana regent dispenser seal for the Benchmark automated staining instruments. |
P100027/S004 11/21/12 Real-Time |
INFORM HER-2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for the change of the two liter (2L) bottles for each of the aqueous-based reagents from fluorinated to non-fluorinated bottles. |
P100029/S008 11/1/12 Real-Time |
Trifecta Heart Valve | St. Jude Medical St. Paul, MN 55117 |
Approval to update the Instructions for Use (IFU), St. Jude Medical (SJM) internet, and any other applicable device labeling to include the new magnetic resonance imaging (MRI) testing information to enhance the safe use of the device when undergoing MRI. |
P100041/S011 11/6/12 180-Day |
Edwards Sapien Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval of the post-approval study protocol. |
P100044/S003 11/9/12 Real-Time |
Propel™ Mini Sinus Implant | Intersect ENT Palo Alto, CA 94303 |
Approval for modifications to the stent crimper and delivery system accessory components of the device. |
P110016/S005 11/29/12 135-Day |
Safire BLU Duo Therapy Ablation Catheters | St. Jude Medical Irvine, CA 92614 |
Approval for an alternate supplier of the catheter shaft subassembly. |
P110019/S031 11/20/12 180-Day |
XIENCE PRIME® Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular, Inc. Temecula, CA 92591 |
Approval to change the manufacturing and testing of the Active Pharmaceutical Ingredient (API) used in the manufacture of the device. |
P110020/S004 11/19/12 Real-Time |
cobas® 4800 BRAF V600 Mutation Test | Roche Molecular Systems, Inc. Pleasanton, CA 94558 |
Approval for changes to the CPU component of the cobas® z480 Analyzer. |
P110043/S003 11/16/12 180-Day |
Omnilink Elite Vascular Balloon-Expandable Stent System | Abbott Vascular Santa Clara, CA 94054 |
Approval for an e-beam sterilization site located at Synergy Health Ireland in Offaly, Ireland. |
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 |
---|---|---|---|
P830037/S054 11/8/12 |
FreshLook (phemfilcon A) Toric Soft Contact Lenses | CIBA Vision Corporation Duluth, GA 30097 |
Change to the production of casting cups. |
P830060/S073 11/9/12 |
Ventak AICD System | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P830061/S081 11/19/12 |
Capsure Sense Lead, Capsure Sense Unipolar Lead, Capsure Sense Bipolar Lead, Vitatron Crystalline Leads | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternative testing system for electrode components. |
P840001/S229 11/2/12 |
Spinal Cord Stimulation, Implantable Neurostimulators, Itrel 4 | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change in the receiving inspection method used on the coated cathode current collector. |
P840068/S051 11/9/12 |
Delta and Vista PGs | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P850079/S058 11/8/12 |
Methafilcon A Soft Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Change in the manufacturing remake process. |
P850079/S059 11/8/12 |
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Decrease in hydration time on Automated Wet Line (AWL) systems. |
P850079/S060 11/20/12 |
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Eliminate secondary repeat testing. |
P850079/S061 11/20/12 |
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Use of fully automated manufacturing equipment in the production of methafilcon A contact lenses. |
P860004/S176 11/2/12 |
Drug Delivery Infusion Pumps SynchroMed Family, SynchroMed II | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change in the receiving inspection method used on the coated cathode current collector. |
P860057/S093 11/13/12 |
Carpentier-Edwards Perimount Pericardial Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Upgrades to the tissue treatment units. |
P860057/S094 11/20/12 |
Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis; Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards Perimount Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Pericardial Aortic Bioprosthesis; Carpentier- Edwards Perimount Magna Pericardial Aortic Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Plus Pericardial Mitral Bioprosthesis; Carpentier-Edwards Perimount Theon Pericardial Mitral Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis; Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis; Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis; and Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue process |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of several ovens for terminal liquid sterilization. |
P860057/S095 11/26/12 |
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis | Edward Lifesciences, LLC Irvine, CA 92614 |
Changes to clean rooms #1, 2 and 3 in the Changi, Singapore facility. |
P870072/S051 11/29/12 |
Thoratec Ventricular Assist Devices | Thoratec Corporation Pleasanton, CA 94588 |
Addition of automated equipment for the annealing process of the device. |
P890003/S264 11/16/12 |
Prodigy IPG | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new cleaning process and a curing oven. |
P890061/S021 11/9/12 |
Ventak P AICD System | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P910073/S108 11/5/12 |
Endotak Lead System | Boston Scientific Corporation St. Paul, MN 55112 |
Modification of the lead test software. |
P910073/S109 11/9/12 |
Endotak ICD Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P910073/S110 11/7/12 |
Reliance/S/G/SG IS-1 (Passive) Defibrillation Leads | Boston Scientific CRM St. Paul, MN 55112 |
Updates to test methods for steroid eluting leads. |
P910073/S111 11/14/12 |
RELIANCE IS-4 Defibrillator Lead | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the rework process to the lead terminal assembly process. |
P910077/S126 11/9/12 |
Ventak PRx and Ventak Mini ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P910077/S127 11/7/12 |
LATITUDE G2 Communicator | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate Surface Mount Technology manufacturing line at the contract manufacturer. |
P910077/S128 11/14/12 |
Latitude PRM | Boston Scientific Corporation St. Paul, MN 55112 |
Moving production of various printed circuit board assemblies to new manufacturing lines and an alternate water wash system at a supplier location. |
P930035/S023 11/9/12 |
Ventak P2 AICD System | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P930039/S076 11/19/12 |
CapSure Fix Novus Lead, Vitatron Crystalline Leads | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternative testing system for electrode components. |
P930039/S077 11/28/12 |
CapSureFix Novus Lead | Medtronic, Inc. Mounds View, MN 55112 |
Replacement laser welding equipment. |
P940008/S030 11/9/12 |
RES-Q and RES-Q Micron ICDs and RES-Q ICD Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P940031/S073 11/9/12 |
Vigor SR/DR, Discovery and Meridian PGs | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P950001/S024 11/9/12 |
Selute Pacing Lead | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P960004/S057 11/9/12 |
Thinline and Fineline Pacing Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P960006/S036 11/9/12 |
Sweet Tip Rx, Sweet Picotip Rx and Flextend Pacing Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P960009/S159 11/2/12 |
DBS Implantable Neurostimulators, Activa SC | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change in the receiving inspection method used on the coated cathode current collector. |
P960040/S275 11/7/12 |
Prizm HE, Vitality/AVT/2, Confient, Punctua, Teligen, Energen and Incepta ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Additional process inspection equipment with software and fixture modifications. |
P960040/S276 11/9/12 |
Ventak AV, Ventak Prizm DR/VR, Vitality, Confient, Livian, and Teligen ICDs |
Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P960040/S277 11/5/12 |
Incepta, Energen, Punctua ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Change to the spot-weld process. |
P960040/S278 11/5/12 |
Incepta, Energen, Punctua Implantable Cardioverter High Energy Defibrillators | Boston Scientific Corporation St. Paul, MN 55112 |
New rework process for components in the header. |
P960040/S279 11/7/12 |
Teligen, Incepta ICD, Energen ICD and Punctua ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of plasma cleaning steps at a supplier. |
P960040/S280 11/29/12 |
Cognis, Incepta, Energen and Punctua Cardiac Resynchronization Therapy Defibrillators | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier for a modified welding component. |
D970003/S141 11/9/12 |
Pulsar, Pulsar Max, Insignia and Altrua PGs | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
D970003/S142 11/7/12 |
Insignia, Advantio, Ingenio and Altrua Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Additional process inspection equipment with software and fixture modifications. |
D970003/S144 11/28/12 |
INGENIO, ANVANTIO Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier for header components. |
P970004/S144 11/2/12 |
Sacral Nerve Stimulation, Urinary, Implantable Neurostimulators, Interstim II | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change in the receiving inspection method used on the coated cathode current collector. |
P970020/S076 11/2/12 |
ULTRA and ZETA RX Coronary Stent Systems | Abbott Vascular Temecula, CA 92589 |
Change to sampling for pyrogen testing. |
P970051/S098 11/20/12 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Re-installation of a laser welder system. |
P980016/S386 11/7/12 |
Maximo II CRT-D and Maximo II, Protecta and Protecta XT ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Change to the burn-in testing process for tantalum capacitors. |
P980016/S387 11/16/12 |
EnTrust, Intrinsic, Marquis DR/VR, Maximo DR/VR, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, and Virtuoso II DR/VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new cleaning process and a curing oven. |
P980035/S297 11/16/12 |
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa, Advisa DR, EnRhythm, Relia, and Sigma DR IPGs |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new cleaning process and a curing oven. |
P990012/S017 11/2/12 |
Elecsys® HBsAg Immunoassay, Elecsys® PreciControl HBsAg, and Elecsys® HBsAg Confirmatory Test | Roche Diagnostics Indianapolis, IN 46250 |
Change to the lyophilization process for components of the assay. |
P990012/S018 11/2/12 |
Elecsys® HBsAg Immunoassay, Elecsys® PreciControl HBsAg, and Elecsys® HBsAg Confirmatory Test | Roche Diagnostics Indianapolis, IN 46250 |
Change to the functional test procedure of an assay component. |
P990046/S030 11/20/12 |
Open Pivot Heart Valve | Medtronic, Inc. Minneapolis, MN 55432 |
Addition of a dual chamber coater. |
P000014/S026 11/13/12 |
VITROS® Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Modifications to the component parts of the Luminometer Signal Processor Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System. |
P000020/S016 11/13/12 |
Bard Ablation System | C.R. Bard, Inc. Lowell, MA 01851 |
Changes to the electrical tester and barcode scanner. |
P000021/S024 11/20/12 |
Dimension TPSA Flex Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. Newark, DE 19714 |
New supplier of Nylon/Surlyn canister film. |
P000044/S030 11/13/12 |
VITROS® Immunodiagnostic Products HBsAg Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Modifications to the component parts of the Luminometer Signal Processor Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System. |
P010012/S307 11/7/12 |
Contak Renewal 3/3 HE, Livian, Punctua, Cognis, Energen and Incepta CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Additional process inspection equipment with software and fixture modifications. |
P010012/S308 11/9/12 |
Contak CD, Livian, and Cognis CRT-Ds; and, Easytrak, Acuity, and Spiral LV Pacing Lead |
Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P010012/S309 11/7/12 |
Acuity Spiral Heart Failure Leads | Boston Scientific CRM St. Paul, MN 55112 |
Updates to test methods for steroid eluting leads. |
P010012/S310 11/5/12 |
Incepta, Energen, Punctua CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Change to the spot-weld process. |
P010012/S311 11/5/12 |
Incepta, Energen, Punctua Cardiac Resynchronization Therapy High Energy Defibrillators | Boston Scientific Corporation St. Paul, MN 55112 |
New rework process for components in the header. |
P010012/S312 11/7/12 |
Cognis, Incepta CRT-D, Energen CRT-D and Punctua CRT-D | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of plasma cleaning steps at a supplier. |
P010012/S313 11/29/12 |
Teligen, Incepta, Energen and Punctua Implantable Cardioverter Defibrillators | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier for a modified welding component. |
P010021/S023 11/13/12 |
VITROS® Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Modifications to the component parts of the Luminometer Signal Processor Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System. |
P010030/S038 11/20/12 |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Modifications to a fixture and a change in the backup battery charging process during the thermal cycling. |
P010031/S338 11/7/12 |
Consulta ICD and Maximo II, Protecta and Protecta XT CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Change to the burn-in testing process for tantalum capacitors. |
P010031/S339 11/16/12 |
Concerto, Consulta, Consulta DF4, InSync III Marquis, and InSync Maximo ICDs; and, Concerto II, Maximo II, Protecta, and Protecta XT CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new cleaning process and a curing oven. |
P020009/S093 11/7/12 |
Express Monorail and OTW Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Replace the component verification system. |
P020009/S095 11/23/12 |
Express 2 Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of several redundant testing requirements from the balloon component manufacturing process. |
P020009/S096 11/23/12 |
Express 2 Coronary Stent System (Monorail & OTW) | Boston Scientific Corporation Maple Grove, MN 55311 |
Removal of several redundant inspections at the Finished Device Inspection step. |
P020027/S019 11/20/12 |
Dimension FPSA Flex Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. Newark, DE 19714 |
New supplier of Nylon/Surlyn canister film. |
P020047/S052 11/2/12 |
VISION and ML8 Coronary Stent Systems | Abbott Vascular Temecula, CA 92589 |
Change to sampling for pyrogen testing. |
P030005/S089 11/7/12 |
Contak Renewal TR/TR 2, and Ivive ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Additional process inspection equipment with software and fixture modifications. |
P030005/S090 11/9/12 |
Contak Renewal TR CRT-P | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P030024/S020 11/13/12 |
VITROS® Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Modifications to the component parts of the Luminometer Signal Processor Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System. |
P030026/S026 11/13/12 |
VITROS® Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Modifications to the component parts of the Luminometer Signal Processor Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System. |
P030036/S050 11/19/12 |
SelectSecure 4 French Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternative testing system for electrode components. |
P040016/S098 11/7/12 |
VeriFLEX (Liberté) Coronary Stent Systems | Boston Scientific Corporation Maple Grove, MN 55311 |
Replace the component verification system. |
P040016/S100 11/23/12 |
VeriFlex (Liberté) Bare Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of several redundant testing requirements from the balloon component manufacturing process. |
P040016/S101 11/23/12 |
VeriFlex Coronary Stent System (Monorail & OTW) | Boston Scientific Corporation Maple Grove, MN 55311 |
Removal of several redundant inspections at the Finished Device Inspection step. |
P040023/S025 11/20/12 |
Duraloc Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Changes to the sealing parameters for two pouch sealers used for SROM Sleeves Blister Packs. |
P040024/S064 11/29/12 |
Restylane Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
Change to a new vision system for the verification of lot number and expiration date for the assembly machine in Factory 1. |
P050006/S032 11/7/12 |
HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Addition of a supplier for polyvinyl alcohol (PVA). |
P050019/S011 11/27/12 |
Carotid WALLSTENT Monorail Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of alternate extrusion lines for components. |
P050039/S013 11/1/12 |
Exactech Novation Ceramic Articulation Hip System | Exactech, Inc. Gainesville, FL 32653 |
Addition of a new blast cabinet. |
P050046/S017 11/9/12 |
Acuity Steerable LV Pacing Lead | Boston Scientific Corporation St. Paul, MN 55112 |
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber. |
P050048/S008 11/13/12 |
MONOLISA™ Anti-HBs EIA | Bio-Rad Laboratories, Inc. Redmond, WA 98052 |
Change to automate the filling and capping process for components in the devices. |
P050051/S016 11/27/12 |
ARCHITECT AUSAB | Abbott Laboratories, Inc. Abbott Park, IL 60064 |
Change to the quality control testing used on an incoming raw material. |
P060001/S018 11/7/12 |
Protégé GPS and Protégé RX Carotid Stent System | Ev3, Inc. Plymouth, MN 55441 |
Alternate microblaster. |
P060006/S034 11/7/12 |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Replace the component verification system. |
P060006/S036 11/23/12 |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Removal of several redundant inspections at the Finished Device Inspection step. |
P060007/S022 11/27/12 |
ARCHITECT HBsAg/ Confirmatory | Abbott Laboratories, Inc. Abbott Park, IL 60064 |
Change to the quality control testing used on an incoming raw material. |
P060031/S006 11/13/12 |
MONOLISA™ Anti-HBc EIA | Bio-Rad Laboratories, Inc. Redmond, WA 98052 |
Change to automate the filling and capping process for components in the devices. |
P060033/S072 11/20/12 |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Changes to the orientation of the sterilization cartons, location of the internal process challenge devices, and modifications to the external process challenge devices used during sterilization. |
P060034/S006 11/13/12 |
MONOLISA™ Anti-HBc IgM EIA | Bio-Rad Laboratories, Inc. Redmond, WA 98052 |
Change to automate the filling and capping process for components in the devices. |
P060035/S015 11/27/12 |
ARCHITECT CORE-M | Abbott Laboratories, Inc. Abbott Park, IL 60064 |
Change to the quality control testing used on an incoming raw material. |
P060038/S015 11/20/12 |
Mitroflow Aortic Pericardial Heart Valve | Sorin Group USA, Inc. Arvada, CO 80004 |
Transfer of component secondary operations from supplier to in-house. |
P070014/S035 11/21/12 |
LifeStent Vascular Stent System | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Addition of an alternate supplier to manufacture larger stent sizes. |
P070015/S102 11/2/12 |
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92589 |
Change to sampling for pyrogen testing. |
P070026/S010 11/20/12 |
DePuy Ceramax Ceramic Total Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Changes to the sealing parameters for two pouch sealers used for SROM Sleeves Blister Packs. |
P080006/S046 11/19/12 |
Attain Ability LV Lead, Attain Ability Plus LV Lead, Attain Ability Straight LV Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternative testing system for electrode components. |
P080012/S009 11/6/12 |
Prometra Programmable Infusion Pump System | Flowonix Medical, Inc. Mt. Olive, NJ 07828 |
Use of an alternate solder paste during the manufacture of the device. |
P080020/S003 11/1/12 |
Gel-One® | Seikagaku Corporation Toyko, Japan 100-0005 |
Replacement of an existing cold storage unit. |
P080020/S004 11/30/12 |
Gel-One® | Seikagaku Corporation Tokyo, Japan |
Increase in production capacity. |
P080023/S016 11/27/12 |
ARCHITECT CORE | Abbott Laboratories, Inc. Abbott Park, IL 60064 |
Change to the quality control testing used on an incoming raw material. |
P080025/S040 11/2/12 |
Sacral Nerve Stimulation, Bowel, Implantable Neurostimulators, InterStim II | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change in the receiving inspection method used on the coated cathode current collector. |
P080026/S004 11/1/12 |
RealTime HBV Assay | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Change to the equipment utilized for identity testing of oligonucleotides. |
P090002/S006 11/20/12 |
Pinnacle CoMplete Acetabular Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Changes to the sealing parameters for two pouch sealers used for SROM Sleeves Blister Packs. |
P090003/S018 11/9/12 |
Express LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an alternate resin compounder. |
P090013/S077 11/16/12 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a new cleaning process and a curing oven. |
P090013/S078 11/19/12 |
CapSureFix MRI Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an alternative testing system for electrode components. |
P090013/S079 11/28/12 |
CapSureFix MRI Lead | Medtronic, Inc. Mounds View, MN 55112 |
Replacement laser welding equipment. |
P090028/S004 11/13/12 |
VITROS® Immunodiag-nostic Products HBeAg Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Modifications to the component parts of the Luminometer Signal Processor Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System. |
P090028/S005 11/26/12 |
VITROS® Immunodiag-nostic Products Anti-HBeAg Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Addition of a supplier for negative human plasma. |
P100001/S003 11/13/12 |
VITROS® Immuno-diagnostic Products Anti-HBe Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Modifications to the component parts of the Luminometer Signal Processor Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System. |
P100001/S004 11/19/12 |
VITROS® Immuno-diagnostic Products Anti-HBe Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Addition of a supplier for negative human plasma. |
P100010/S020 11/7/12 |
Arctic Front & Arctic Front Advance Cardiac CryoAblation Catheters | Medtronic CryoCath LP Quebec, Canada H9R 5Z8 |
Use of an automatic pull wire crimper. |
P100010/S021 11/20/12 |
Arctic Front Advance Cardiac CryoAblation Catheters | Medtronic, Inc. Mounds View, MN 55112 |
Change to a semi-automated sanding method at a component supplier. |
P100017/S003 11/1/12 |
RealTime HCV Assay | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Change to the equipment utilized for identity testing of oligonucleotides. |
P100020/S007 11/6/12 |
cobas® HPV Test | Roche Molecular Systems, Inc Pleasanton, CA 94588 |
Change of resin for closures, and an addition of new filling and capping equipment. |
P100021/S022 11/20/12 |
Endurant Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Reduction to the incoming inspection for a component assembly. |
P100023/S056 11/5/12 |
ION Paclitaxel-Eluting Platinum Chromium Coronary | Boston Scientific Corporation Maple Grove, MN 55311 |
Manufacturing software changes pertaining to the catheters. |
P100023/S057 11/20/12 |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Changes to proximal balloon bond manufacturing software. |
P100023/S058 11/23/12 |
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of several redundant testing requirements from the balloon component manufacturing process. |
P100023/S059 11/23/12 |
ION (Taxus Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a second injection molding line for manifold-hypotube assemblies. |
P100023/S060 11/29/12 |
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification of the distal heat shrink alignment software. |
P100023/S061 11/23/12 |
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Updates to the visual standard inspection criteria for gouges. |
P100023/S062 11/23/12 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software upgrade to the Visicon Inspection System. |
P100041/S015 11/13/12 |
Carpentier-Edwards P erimount, Edwards SAPIEN Transcatheter Heart Valve |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Upgrades to the tissue treatment units. |
P110003/S002 11/13/12 |
LeGoo Endovascular Occlusion Gel | Pluromed, Inc. Woburn, MA 01801 |
Changes to the packaging configurations of the device. |
P110003/S003 11/13/12 |
LeGoo Endovascular Occlusion Gel | Pluromed, Inc. Woburn, MA 01801 |
Changes to the packaging configurations by reducing the number of Tyvek pouched cannulae per sales carton. |
P110010/S031 11/5/12 |
Promus Element Plus Everolimus-Eluting Platinum | Boston Scientific Corporation Maple Grove, MN 55311 |
Manufacturing software changes pertaining to the catheters. |
P110010/S032 11/20/12 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Changes to proximal balloon bond manufacturing software. |
P110010/S033 11/23/12 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a second injection molding line for manifold-hypotube assemblies. |
P110010/S034 11/29/12 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification of the distal heat shrink alignment software. |
P110010/S036 11/23/12 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Updates to the visual standard inspection criteria for gouges. |
P110010/S037 11/23/12 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software upgrade to the Visicon Inspection System. |
P110019/S035 11/2/12 |
XIENCE PRIME and XIENCE PRIME LL Everlimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92589 |
Change to sampling for pyrogen testing. |
P110023/S004 11/7/12 |
Everflex Self-Expanding Peripheral Stent System | Ev3, Inc. Plymouth, MN 55441 |
Alternate microblaster. |
P110028/S005 11/14/12 |
Absolute Pro Vascular Self-Expanding Stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Modify the stent subassembly expansion process. |
P110029/S006 11/19/12 |
ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Change to a quality control test method for purified antibodies used in the manufacture of the ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory assays. |
P110029/S007 11/27/12 |
ARCHITECT HBsAg Qualitative/ Confirmatory | Abbott Laboratories, Inc. Abbott Park, IL 60064 |
Change to the quality control testing used on an incoming raw material. |
P110035/S004 11/7/12 |
Epic Vascular Self- Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Replace the component verification system. |