PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P090024 10/11/11 |
ADVIA Centaur HBeAg Assay and ADVIA Centaur HBeAg Quality Control Material | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for ADVIA Centaur HBeAg Assay & ADVIA Centaur HBeAg Quality Control Material. This device is indicated for: ADVIA Centaur HBeAg Assay: The ADVIA Centaur HBeAg assay is an in-vitro diagnostic immunoassay for the qualitative determination of the hepatitis B e antigen (HBeAg) in human serum and plasma (potassium EDTA, lithium or sodium heparin) from individuals who have signs and symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the ADVIA Centaur and ADVIA Centaur XP systems. This assay, in conjunction with other serological and clinical information, is intended only for the determination of chronic infection with hepatitis B virus. ADVIA Centaur HBeAg Quality Control Material: The controls are used for monitoring the performance of the HBeAg Assay on the ADVIA Centaur Systems. The performance of the HBeAg quality control material has not been established with any other HBeAg assay. |
P100042 10/28/11 |
APTIMA HPV Assay | Gen-Probe Incorporated San Diego, CA 92121 |
Approval for the APTIMA HPV Assay. APTIMA HPV Assay Indications For Use: The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection Of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/ spatula collection devices* may be tested with the APTIMA HPV Assay. The assay is used with the TIGRIS DTS System. The use of the test is indicated: 1. To screen patients 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy. 2. In women 30 years and older, the APTIMA HPV Assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. * Broom-type device (e.g., Wallach Pipette) or endocervical brush/spatula. |
P110011 10/26/11 |
Assurant® Cobalt Iliac Balloon-Expandable Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the Assurant® Cobalt Iliac Balloon-Expandable Stent System. This device is indicated for improving iliac luminal diameter in patients with de novo and restenotic lesions in the common and external iliac arteries, with reference vessel diameters between 6 mm and 10 mm and lesion lengths up to 61 mm. The stent is intended as a permanent implant. |
P110022 10/26/11 |
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 601 Immunoassay Analyzer | Roche Diagnostics Indianapolis, IN 46250 |
Approval for the Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 601 Immunoassay Analyzer. This device is indicated for: Elecsys Anti-HBc IgM Immunoassay The Elecsys Anti-HBc IgM Immunoassay is intended for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate). The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection, The Elecsys Anti-HBc IgM Immunoassay’s performance has not been established for the monitoring of HBV disease or therapy. The electrochemilu-minescence Immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer. PreciControI Anti-HBc IgM Elecsys PreciControl Anti-HBc IgM is used for quality control of the Elecsys Anti-HBc IgM Immunoassay on the cobas e 601 immunoassay analyzer. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P860003/S062 10/28/11 Special |
THERAKOS CELLEX™ Photopheresis System | Therakos, Inc. Raritan, NJ 08869 |
Approval for a Technical Bulletin that will be sent out to users of the CELLEX™ system. |
P880086/S210 10/14/11 180-Day |
Sustain XL SC, DC, SR, DR Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Cardiac Rhythm Management Division in Penang, Malaysia. |
P890070/S005 10/7/11 180-Day |
Pure-Dent B851 Absorbable Dusting Powder | Grain Processing Corporation Muscatine, IA 52761 |
Approval for a manufacturing site located at PacMoore Process Technologies, LLC, in Mooresville, Indiana. |
P910001/S049 10/25/11 Real-Time |
CVX Excimer Laser System | Spectranetics Corporation Colorado Springs, CO 80921 |
Approval for software changes to the CVX-300 and CVX-300-P Laser Systems. |
P910023/S240 10/20/11 Real-Time |
Neutrino 2, Shiva, and Shiva 2 High Voltage Capacitors | St. Jude Medical Sylmar, CA 91342 |
Approval for Neutrino 2, Shiva, and Shiva 2 High Voltage Capacitors |
P930014/S055 10/31/11 Real-Time |
AcrySof® Intraocular Lens (IOL) and AcrySof® ReSTOR® IOL | Alcon Research, LTD Fort Worth, TX 76134 |
Approval for modifications to the AcrySof® Intraocular Lens (IOL) case (#79 and #80) drainage features. |
P930014/S048 10/25/11 180-Day |
Acrysof® Toric and Acrysof® IQ Toric High Cylinder Power IOLs | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for post-approval study protocol. |
P930038/S068 10/18/11 Real-Time |
Angio-Seal™ Vascular Closure Device | St. Jude Medical St. Paul, MN 55117 |
Approval to increase the Denaturation Temperature range to 42.41 – 53.3˚C. |
P970003/S065 10/17/11 Real-Time |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Approval for labeling changes related to the use of MRI systems with the device. |
P970003/S135 10/31/11 Real-Time |
VNS Therapy System Demipulse Generators | Cyberonics, Inc. Houston, TX 77058 |
Approval for an upgrade to the Communication Flash Loader (CFL) portion of the firmware of the Demipulse Implantable Pulse Generators, Model 103 and Model 104. |
P970020/S064 10/4/11 135-Day |
MultiLink Zeta Coronary Stent System | Abbott Vascular Temecula, CA 92590 |
Approval for automation of the existing balloon necking process. |
P970027/S015 10/7/11 Special |
AxSYM Anti-HCV | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a quality control test of an incoming raw material for the AxSYM Anti-HCV, ARCHITECT CORE-M and AxSYM CORE. |
P970051/S085 10/4/11 Real-Time |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for a modified version of the Earhook attachment to the device, which involves a change in material. |
P980016/S321 10/31/11 Real-Time |
Entrust, Intrinsic, Marquis, Onyx, Secura, Gem, Maximo, Protecta and Virtuoso | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an update to the life test specifications of high voltage capacitors. |
P980022/S071 10/20/11 180-Day |
iPro2 Professional Continuous Glucose Monitoring (CGM) System | Medtronic MiniMed Northridge, CA 91325 |
Approval for incorporating a USB connection for data upload, changing the operating time before recharging, changing to a web-based software system, and incorporating a docking station and cleaning plug. The device, as modified, will be marketed under the trade name iPro2 Professional Continuous Glucose Monitoring (CGM) System (MMT-7745). |
P980022/S093 10/14/11 Real-Time |
Continuous Glucose Monitoring System | Medtronic MiniMed Northridge, CA 91325 |
Approval for minor modifications to the pump case bottom cover to reduce the Rib (A) width dimensions, affecting the Paradigm Real-Time pump models MMT-722, MMT-722K, MMT-723 and MMT-723K. |
P000032/S036 10/12/11 180-Day |
Her Option Cryoablation Therapy System | CooperSurgical, Inc. Trumbull, CT 06611 |
Approval for a manufacturing site located at CooperSurgical, Inc. in Trumbull, Conneticut. |
P000058/S046 10/5/11 Real-Time |
INFUSE® Bone Graft/L-T Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 31832 |
Approval for replacing the Plastisol caps used to hold the fusion cage component with polyethylene bags. |
P010029/S008 10/11/11 Panel-Track |
EUFLEXXA® | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Approval for EUFLEXXA ® (1 % sodium hyaluronate). This device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen). |
P010031/S275 10/31/11 Real-Time |
Consulta, Maximo II, Concerto, Insync | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an update to the life test specifications of high voltage capacitors. |
P010032/S041 10/28/11 Real-Time |
Genesis and Eon Family Neurostimulation (IPG) Systems | St. Jude Medical Plano, TX 75024 |
Approval for a modification to the amplitude button of the patient programmer that added material to prevent off-center actuations. |
P010033/S019 10/20/11 Special |
QuantiFERON® TB Gold | Cellestis, Incorporated Valencia, CA 91355 |
Approval for changes to the labeling: Instructions for Use section, Specimen Collection and Handling section, and Abbreviated Test Procedure section for use of the QuantiFERON® Blood Collection tubes. |
P020041/S002 10/13/11 180-Day |
FemCap | FemCap, Inc. Del Mar, CA 92014 |
Approval for a manufacturing site located at Helix Medical, LLC. in Carpinteria, CA 93013 |
P020047/S035 10/4/11 135-Day |
Vision and ML8 Coronary Stent Systems | Abbott Vascular Temecula, CA 92590 |
Approval for automation of the existing balloon necking process. |
P030017/S119 10/21/11 180-Day |
Precision® Spinal Cord Stimulation (SCS) System | Boston Scientific Neuromodulation Valencia, CA 91355 |
Approval for the Infinion 1×16 Percutaneous Lead and 2×8 Splitter. |
P030022/S017 10/14/11 135-Day |
REFLECTION Ceramic Acetabular Hip System (RCHS) and BIRMINGHAM HIP Resurfacing System (BHR) | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for the addition of an alternative site for the porous coating process for the R3 Acetabular Shells. |
P030054/S159 10/20/11 Real-Time |
Neutrino 2, Shiva, and Shiva 2 High Voltage Capacitors | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Neutrino 2, Shiva, and Shiva 2 High Voltage Capacitors. |
P030054/S200 10/20/11 Real-Time |
Merlin Patient Care System | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for changes to the internal components of the device. |
P040020/S036 10/31/11 Real-Time |
AcrySof® Intraocular Lens (IOL) and AcrySof® ReSTOR® IOL | Alcon Research, LTD Fort Worth, TX 76134 |
Approval for modifications to the AcrySof® Intraocular Lens (IOL) case (#79 and #80) drainage features. |
P040021/S018 10/13/11 135-Day |
Biocor & Epic Valves | St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for a change in the jar set assembly packaging and ethylene oxide sterilization load configuration. |
P040024/S051 10/11/11 Panel-Track |
Restylane Injectable Gel | Medicis Aesthetics, Inc. Scottsdale, AZ 85256 |
Approval for Restylane Injectable Gel. This device is indicated for: 1) mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds; and 2) submucosal implantation for lip augmentation in patients over the age of 21. |
P040033/S017 10/14/11 135-Day |
REFLECTION Ceramic Acetabular Hip System (RCHS) and BIRMINGHAM HIP Resurfacing System (BHR) | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for the addition of an alternative site for the porous coating process for the R3 Acetabular Shells. |
P040037/S036 10/27/11 135-Day |
VIABAHN Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for an alternate supplier of the drug coating component of the device. |
P040044/S034 10/4/11 180-Day |
Mynx™ with Grip Technology™ | Access Closure Mountain View, CA 94043 |
Approval for a modified version of the Mynx Vascular Closure Device called the Mynx™ Vascular Closure Device with Grip Technology™. |
P050006/S020 10/13/11 135-Day |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval to modify an acceptance criterion for the control catheter component. |
P050010/S009 10/4/11 135-Day |
ProDisc™ Total Disc Replacement | Synthes Spine West Chester, PA 19380 |
Approval for a change from a manual polishing process to an automated polishing process and the addition of a passivation process after the plasma coating process. |
P050037/S024 10/31/11 180-Day |
Radiesse | Merz Aesthetics, Inc. Franksville, WI 53126 |
Approval for a new product fill volume (i.e., 3.0cc). |
P050052/S027 10/31/11 180-Day |
Radiesse | Merz Aesthetics, Inc. Franksville, WI 53126 |
Approval for a new product fill volume (i.e., 3.0cc). |
P060012/S008 10/7/11 Special |
AxSYM CORE | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a quality control test of an incoming raw material for the AxSYM Anti-HCV, ARCHITECT CORE-M and AxSYM CORE. |
P060022/S010 10/21/11 180-Day |
Akreos Posterior Chamber Intraocular Lens (IOL) | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Approval for the removal of verbiage pertaining to the clinical assessment of the addition of the aspheric surface. |
P060033/S066 10/25/11 135-Day |
Endeavor Sprint Zotarlimus-Eluting Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Approval for a change to the drug spray in-process controls. |
P060035/S010 10/7/11 Special |
ARCHITECT CORE-M | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a quality control test of an incoming raw material for the AxSYM Anti-HCV, ARCHITECT CORE-M and AxSYM CORE. |
P070014/S023 10/27/11 180-Day |
LifeStent Vascular Stent System | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Approval for a manufacturing site located at Angiomed GmbH & Co. in Karlsruhe, Germany. |
P070014/S026 10/26/11 Special |
Bard LifeStent SOLO Vascular Stent System | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Approval for modifications to the product labeling, predominantly with respect to improving the safe use of the device by modifying the stent deployment procedure language in the Instructions for Use, as well as adding new symbols to the labeling. |
P070015/S072 10/4/11 135-Day |
XIENCE V and PROMUS Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92590 |
Approval for automation of the existing balloon necking process. |
P080025/S021 10/11/11 180-Day |
InterStim Sacral Nerve Stimulation Therapy for Bowel Control | Medtronic, Inc. Minneapolis, MN 55432 |
Approval of post-approval protocol. |
P080027/S003 10/20/11 135-Day |
OraQuick® Rapid HCV Antibody Test | OraSure Technologies, Inc. Bethlehem, PA 18015 |
Approval for hold time extensions for raw material, components and in-process material for the manufacturing of the device. |
P090018/S013 10/28/11 Real-Time |
Esteem® | Envoy Medical Corporation Saint Paul, MN 55110 |
Approval for user interface firmware changes to the Esteem Personal Programmer. |
P100014//S004 10/27/11 180-Day |
Solesta Injectable Bulking Agent | Ocean Therapeutics, Inc. Edison, NJ 08817 |
Approval of the post-approval protocol. |
P100023/S002 10/25/11 135-Day |
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for changes to In-Process Monitoring (IPM) requirements. |
P100027/S001 10/13/11 Real-Time |
INFORM HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for modification of the stability testing protocol to allow for extension of the shelf life of the device from 6 months to 18 months. |
P100029/S004 10/13/11 135-Day |
Trifecta Valve | St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for a change in the jar set assembly packaging and ethylene oxide sterilization load configuration. |
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 |
---|---|---|---|
D970012/S089 10/26/11 |
AMS Model 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Change in the packaging process for the devices. |
P780007/S046 10/21/11 |
Biomedics 38 (Polymacon) Soft (Hydrophilic) Contract Lenses | CooperVision Incorporated Pleasanton, CA 94588 |
Addition of sterilization cycle runs for single blisters, CVI blisters and six pack blisters to sterilizer Fedegari. |
P840001/S196 10/21/11 |
Restore Family of Implantable Neurostimulators | Medtronic, Inc. Minneapolis, MN 55432 |
Implement software updates to the Self Test application of the Next Generation Tester. |
P850068/S009 10/14/11 |
Bausch & Lomb Silsoft (elastofilcon A) Contact Lenses | Bausch & Lomb Incorporated Rochester, NY 14609 |
Change the manufacturing process of the optical tools used to manufacture the device. |
P870025/S010 10/12/11 |
Fetal Acoustic Stimulator (FAST) | Wipro GE Healthcare Laurel, MD 20723 |
Changes to the suppliers for components of the FAST device. |
P890003/S236 10/21/11 |
Prodigy | Medtronic, Inc. Mounds View, MN 55112 |
Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier. |
P910023/S274 10/7/11 |
Fortify ICDs | St. Jude Medical Sylmar, CA 91392 |
Changes to the limits for a device level manufacturing test as well as the addition of in-process verification tests. |
P910023/S275 10/12/11 |
Fortify ICDs | St. Jude Medical Sylmar, CA 91392 |
Use of an alternate supplier for back-up bands. |
P940015/S022 10/7/11 |
Synvisc® and Synvisc-One® | Genzyme Corporation Cambridge, MA 02142 |
Addition of a syringe assembly machine to the packaging department. |
P940015/S023 10/7/11 |
Synvisc® and Synvisc-One® | Genzyme Corporation Cambridge, MA 02142 |
Addition of a raw material identification system and an automated filter integrity test instrument. |
P950005/S035 10/7/11 |
Celsius, Celsius RMT, EZ Steer, EZ Steer DS, Non-Temperature Sensing Ablation Catheters and Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Parametric release of sterilized product using ethylene oxide. |
P960009/S127 10/21/11 |
Activa Family of Implantable Neurostimulators | Medtronic, Inc. Minneapolis, MN 55432 |
Implement software updates to the Self Test application of the Next Generation Tester. |
P960013/S067 10/6/11 |
Tendril Family of Leads | St Jude Medical, Inc. Sylmar, CA 91342 |
Increase the length of the ring electrode masking. |
P960040/S246 10/26/11 |
Cognis CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier of ceramic capacitor used for pulse generator (PG) manufacturing. |
P960058/S092 10/26/11 |
Harmony HiResolution Bionic Ear System | Advanced Bionics Corporation Sylmar, CA 91342 |
Change in the manufacturing process to improve an insertion tool and to document a change in the tool suppliers. |
P970003/S136 10/18/11 |
VNS Therapy® Pulse Generators | Cyberonics, Inc. Houston, TX 77058 |
Change to inventory control and traceability of components and subassemblies. |
P970003/S137 10/21/11 |
VNS Therapy® System | Cyberonics, Inc. Houston, TX 77058 |
Change in the acceptance criteria for the Model 102/102R Pulse Generators. |
P970003/S138 10/27/11 |
VNS Therapy® System | Cyberonics, Inc. Houston, TX 77058 |
Implementation of Statistical Process Control (SPC) software. |
P970008/S059 10/26/11 |
Urologix Targis System for the Treatment of BPH | Urologix, Inc. Minneapolis, MN 55447 |
Change in adhesive in the manufacturing of the Urologix Targis System control units. |
P970020/S069 10/28/11 |
Multi-Link Zeta and Ultra Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Automated process for preparation of the adaption cup. |
P970027/S016 10/19/11 |
AxSYM Anti HCV | Abbott Laboratories Abbott Park, IL 60064 |
Relocation of a formulation room for the lyophilization of alkaline-treated casein used in the device. |
P980016/S322 10/13/11 |
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, and Virtuoso II ICDs |
Medtronic, Inc. Mounds View, MN 55112 |
Software updates for a testing application. |
P980035/S241 10/13/11 |
Adapta, Advisa, EnRhythm, Relia, Sensia, and Versa IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Software updates for a testing application. |
P980035/S243 10/21/11 |
350 Series, Adapta, EnPulse, EnRhythm, Relia, Sensia, Sigma and Versa | Medtronic, Inc. Mounds View, MN 55112 |
Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier. |
P990001/S095 10/13/11 |
Vitatron DA+ C-Series and Vitatron DA+ T-Series IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Software updates for a testing application. |
P990001/S097 10/21/11 |
Vitatron DA+ C-Series IPG | Medtronic, Inc. Mounds View, MN 55112 |
Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier. |
P990025/S029 10/7/11 |
NaviStar, NaviStar RMT, EZ Steer Nav, QwikStar Catheters and Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Parametric release of sterilized product using ethylene oxide. |
P990071/S015 10/7/11 |
Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Parametric release of sterilized product using ethylene oxide. |
P000010/S025 10/11/11 |
AMPLICOR HCV Test, v2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Changes to the room location and equipment for filling and labeling of certain vialed intermediate components. |
P000012/S035 10/11/11 |
COBAS AMPLICOR HCV Test, v2.0 and COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, v2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Changes to the room location and equipment for filling and labeling of certain vialed intermediate components. |
P000039/S042 10/21/11 |
AMPLATZER Septal Occluder AMPLATZER 45 Delivery and Exchange Systems | AGA Medical Corporation Plymouth, MN 55442 |
Change the current seal test method from manual to semiautomatic. |
P000040/S019 10/3/11 |
HTA System ProCerva Procedure Set | Boston Scientific Corporation Marlborough, MA 01752 |
Addition of a new manufacturing fixture and the modifications of an existing manufacturing fixture. |
P000053/S039 10/26/11 |
AMS 800 Urinary Control System | American Medical Systems Minnetonka, MN 55343 |
Change in the packaging process for the devices. |
P010012/S272 10/26/11 |
Teligen ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier of ceramic capacitor used for pulse generator (PG) manufacturing. |
P010015/S138 10/13/11 |
Consulta and Syncra CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Software updates for a testing application. |
P010015/S140 10/21/11 |
InSync III | Medtronic, Inc. Mounds View, MN 55112 |
Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier. |
P010019/S026 10/28/11 |
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended Wear | CIBA VISION Corporation Duluth, GA 30097 |
Addition of an alternate supplier for Isopropyl Alcohol (IPA). |
P010020/S021 10/26/11 |
Acticon Neosphincter | American Medical Systems Minnetonka, MN 55343 |
Change in the packaging process for the devices. |
P010030/S030 10/26/11 |
LifeVest Wearable Cardioverter Defibrillator | ZOLL Lifecor Corporation Pittsburgh, PA 15238 |
Alternate supplier for the holster and a change to the incoming inspection sampling plan. |
P010031/S276 10/13/11 |
Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, and Protecta XT ICDs |
Medtronic, Inc. Mounds View, MN 55112 |
Software updates for a testing application. |
P010047/S013 10/19/11 |
ProGel™ Pleural Air Leak Sealant | Neomend, Inc. Irvine, CA 92618 |
Reduction in sample size of the current testing for the applicator kits. |
P010068/S025 10/7/11 |
Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS, QwikStar DS Catheters and Interface Cables | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Parametric release of sterilized product using ethylene oxide. |
P020004/S065 10/24/11 |
GORE EXCLUDER AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change to visual inspection criteria for the stent graft deployment line fiber. |
P020004/S066 10/27/11 |
GORE EXCLUDER AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Update in bacterial endotoxin testing software. |
P020009/S078 10/19/11 |
Express and Express 2 Coronary Stent Systems | Boston Scientific Corporation Maple Grove, MN 55311 |
Additional sterilization cycle for the device. |
P020009/S079 10/31/11 |
Express Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Process settings to be optimized or defined for extrusion of the proximal outer component. |
P020024/S034 10/21/11 |
AMAPLATZER Duct Occluder 180 Delivery and Exchange System | AGA Medical Corporation Plymouth, MN 55442 |
Change the current seal test method from manual to semiautomatic. |
P020045/S040 10/7/11 |
Freezor Cardiac CryoAblation Catheter, Freezor Xtra Surgical and Freezor MAX Surgical CryoAblation Devices | Medtronic CryoCath LP Pointe Claire, Quebec H9R5Z8 |
Change to reduce adhesive curing time for ECG rings and the tip electrode. |
P020047/S040 10/28/11 |
Multi-Link Vision, Multi-Link Mini Vision, ML8 Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Automated process for preparation of the adaption cup. |
P020052/S008 10/13/11 |
Response™ CV Cardioversion Electrophysiology Catheter and System Accessory Equipment | St. Jude Medical, Inc. Minnetonka, MN 55345 |
Eliminate the UV Post Trim process. |
P030009/S060 10/19/11 |
Driver OTW Stent System | Medtronic, Inc. Santa Rosa, CA 95403 |
Changing the product print information from a manual process to an automated process. |
P030017/S123 10/12/11 |
Precision® Spinal Cord Stimulator System | Boston Scientific Neuromodulation Valencia, CA 91355 |
Add an alternative welder for the antenna welding process. |
P030031/S035 10/7/11 |
Celsius ThermoCool, Celsius RMT ThermoCool, NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool and EZ Steer ThermoCool Nav Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Parametric release of sterilized product using ethylene oxide. |
P030032/S013 10/7/11 |
PREVELLE Silk | Genzyme Corporation Cambridge, MA 02142 |
Addition of a raw material identification system and an automated filter integrity test instrument. |
P030054/S201 10/7/11 |
Unify CRT-Ds | St. Jude Medical Sylmar, CA 91392 |
Changes to the limits for a device level manufacturing test as well as the addition of in-process verification tests. |
P030054/S203 10/12/11 |
Unify CRT-Ds | St. Jude Medical Sylmar, CA 91392 |
Use of an alternate supplier for back-up bands. |
P040016/S078 10/14/11 |
VeriFLEX (Liberté) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Implementation of a semi-automated kitting process of accessory kits at a contract supplier. |
P040016/S079 10/19/11 |
VeriFLEX OTW Bare Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Updates to the Hydrophilic Coating (HPC) equipment process. |
P040016/S080 10/31/11 |
VeriFLEX Coronary Stent System (Formerly Liberté) | Boston Scientific Corporation Maple Grove, MN 55311 |
Process settings to be optimized or defined for extrusion of the proximal outer component. |
P040016/S081 10/31/11 |
VeriFLEX (Liberté) Bare Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Hardware and software updates for the Plasma Treater. |
P040020/S038 10/6/11 |
AcrySof Intraocular Lenses (IOLs) | Alcon Research, Ltd. Fort Worth, TX 76134 |
Modifications to the final cleaning process. |
P040027/S025 10/27/11 |
GORE VIATORR TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Final product assembly at the firm’s Phoenix location. |
P040027/S026 10/27/11 |
GORE VIATORR TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Update in bacterial endotoxin testing software. |
P040036/S026 10/7/11 |
NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool and EZ Steer ThermoCool Nav Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Parametric release of sterilized product using ethylene oxide. |
P040037/S038 10/27/11 |
GORE VIABAHN Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Update in bacterial endotoxin testing software. |
P040040/S019 10/21/11 |
AMPLATZER Muscular VSD Occluder | AGA Medical Corporation Plymouth, MN 55442 |
Change the current seal test method from manual to semiautomatic. |
P040043/S042 10/24/11 |
GORE TAG Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change to visual inspection criteria for the stent graft deployment line fiber. |
P040043/S043 10/27/11 |
GORE TAG THORACIC Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Update in bacterial endotoxin testing software. |
P040045/S025 10/12/11 |
VISTAKON (senofilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Upgrade to the saline dose head during the manufacturing of the device. |
P040045/S027 10/26/11 |
Vistakon (senofilcon A) Contact Lenses, Clear & Visibly Tinted with UV Blocker | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Update the current test method for Vistakon (senofilcon A) Contact Lenses. |
P050006/S021 10/21/11 |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Replacement of sand paper with a lock loop polishing tool in the manufacture of the subject device. |
P050006/S022 10/27/11 |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Addition of a procedure for inventory processing. |
P050006/S023 10/19/11 |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AX 86001 |
Addition of Expiry Report requirement to the return product procedure. |
P050006/S024 10/27/11 |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Update in bacterial endotoxin testing software. |
P050006/S026 10/28/11 |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Adoption of an instruction for single piece flow in the boxing operation. |
P050018/S015 10/27/11 |
AngioSculpt PTCA Scoring Balloon Catheter | Angioscore, Inc. Fremont, CA 94538 |
Remove redundant in-process inspection tests. |
P050028/S022 10/11/11 |
COBAS TaqMan HBV Test For Use with The High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test v2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Changes to the room location and equipment for filling and labeling of certain vialed intermediate components. |
P060002/S021 10/31/11 |
Bard Flair Endovascular Stent Graft | C.R. Bard, Inc. Tempe, AZ 85281 |
Introduction of an automated labeling inspection system and introduction of a new barcode scan system. |
P060003/S010 10/3/11 |
Abbott AxSYM AUSAB | Abbott Laboratories Abbott Park, IL 60064 |
Change to vendor for the incoming Non-Fat Dry Milk. |
P060008/S077 10/14/11 |
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Implementation of a semi-automated kitting process of accessory kits at a contract supplier. |
P060008/S078 10/14/11 |
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the feedstock source for the manufacturing of a solvent. |
P060008/S079 10/19/11 |
TAXUS Liberté OTW Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Updates to the Hydrophilic Coating (HPC) equipment process. |
P060008/S080 10/31/11 |
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Process settings to be optimized or defined for extrusion of the proximal outer component. |
P060008/S081 10/31/11 |
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Hardware and software updates for the Plasma Treater. |
P060022/S009 10/7/11 |
Akreos Posterior Chamber Intraocular Lenses | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Transfer of bioburden testing of the Akreos Adapt AO Holder Folder, M160 Holder, and Parker Gasket from a contract vendor to Bausch & Lomb. |
P060030/S023 10/11/11 |
COBAS AmpliPrep/ COBAS TaqMan HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Changes to the room location and equipment for filling and labeling of certain vialed intermediate components. |
P060033/S068 10/19/11 |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic, Inc. Santa Rosa, CA 95403 |
Changing the product print information from a manual process to an automated process. |
P070007/S032 10/19/11 |
Talent Thoracic Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Modification of a wiping procedure. |
P070014/S024 10/7/11 |
LifeStent Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Change to the tensile testing process. |
P070014/S028 10/31/11 |
LifeStent Vascular Stent | C.R. Bard, Inc. Tempe, AZ 85281 |
Introduction of an automated labeling inspection system and introduction of a new barcode scan system. |
P070015/S081 10/28/11 |
XIENCE V and PROMUS Everolimus-Eluting Coronary Stent | Abbott Vascular, Inc. Temecula, CA 92591 |
Automated process for preparation of the adaption cup. |
P070027/S033 10/19/11 |
Abdominal Stent Graft with the Xcelerent System, Talent Converter Stent Graft with the Xcelerant System | Medtronic Vascular Santa Rosa, CA 95403 |
Modification of a wiping procedure. |
P080004/S009 10/26/11 |
Hoya iSpheric | Hoya Surgical Optics, Inc. Chino Hills, CA 91709 |
Change to the endotoxin testing method. |
P080007/S008 10/31/11 |
E-LUMINEXX Vascular Stent Graft | C.R. Bard, Inc. Tempe, AZ 85281 |
Introduction of an automated labeling inspection system and introduction of a new barcode scan system. |
P090013/S039 10/13/11 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Software updates for a testing application. |
P090028/S001 10/21/11 |
VITROS Immunodiagnostic Products HBeAg Reagent Pack and VITROS Immunodiagnostic Products HBeAg Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Conversion of the in-process limit for the process control of the selling calibrator from a signal ratio to a numerical test result. |
P100010/S012 10/7/11 |
Freezor MAX Cardiac CryoAblation Catheter | Medtronic CryoCath LP Pointe Claire, Quebec H9R5Z8 |
Change to reduce adhesive curing time for ECG rings and the tip electrode. |
P100023/S020 10/6/11 |
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of the ION Stent System to sterilization Chamber 6 at Coventry, Rhode Island. |
P100023/S021 10/14/11 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the feedstock source for the manufacturing of a solvent. |
P100023/S022 10/19/11 |
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Updates to the Hydrophilic Coating (HPC) equipment process. |
P100023/S023 10/27/11 |
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the in-process monitoring plan for proximal and port welds. |
P100023/S024 10/19/11 |
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Updates to the Marker Band and DVT equipment inspection software. |
P100023/S025 10/28/11 |
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Modification to the sampling plan for the laser cutting set up. |
P100023/S026 10/31/11 |
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Hardware and software updates for the Plasma Treater. |
P100029/S009 10/19/11 |
Trifecta Valve | St. Jude Medical, Inc. St. Paul, MN 55117 |
Change to the in-process limit for total valve score during the visual inspection and functional test. |
P110020/S001 10/17/11 |
cobas® 4800 BRAF V600 mutation test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Addition of functional testing at the final vial stage in the manufacture of the device mutation positive control (MU) and the wild-type control (WT). |
P110020/S002 10/26/11 |
cobas® 4800 BRAF V600 mutation test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Changes to the filling and labeling equipment and location for certain vialed intermediate components. The firm has proposed relocation to Building 502 Rooms 1F24 and 1F26 from Building 502 Rooms 1F23 and 1F31 for use of new equipment Kugler Linoline 120 Filing and Screw-capping Line which includes the Accraply 4000 and 35T Labeling Machines. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 52
Summary of PMA Originals Under Review
Total Under Review: 88
Total Active: 41
Total On Hold: 47
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 554
Total Active: 437
Total On Hold: 117
Number Greater Than 180 Days: 11
Summary of All PMA Submissions Received
Originals: 2
Supplements: 66
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 52
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 210.9
FDA Time: 127.9 Days MFR Time: 83 Days