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Medical Devices
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March 2008 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.
PMA Original Approvals
| P050020 3/12/08 |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda , CA 94502 |
Approval for the FreeStyle Navigator Continuous Glucose Monitoring System. The device is indicated for the following: The FreeStyle Navigator Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator Continuous Glucose Monitoring System, traditional blood glucose tests must be performed. The FreeStyle Navigator Continuous Glucose Monitoring System provides a built-in blood glucose meter to confirm the continuous glucose result. The FreeStyle Navigator Continuous Glucose Monitoring System provides real-time readings, graphs, trends and glucose alarms directly to the user. The FreeStyle Navigator Continuous Glucose Monitoring System is intended to be used in home settings to aid people with diabetes in predicting and detecting episodes of hypoglycemia and hyperglycemia and in clinical settings to aid healthcare professionals in evaluating glucose control. The FreeStyle Navigator Continuous Glucose Monitoring System is available only by prescription. |
PMA Supplemental Approvals
| P820060/S022 3/26/08 Real-Time |
AxSYM® AFP | Abbott Laboratories Abbott Park , IL 60064 | Approval for re-standardization of the manufacturing process for AxSYM AFP calibrators and controls against the World Health Organization (WHO) First International Standard 72/225 or alpha-fetoprotein (AFP). |
| P830055/S101 3/13/08 Real-Time |
LCS Total Knee System – LCS Complete RPS Flexion Femoral Component | DePuy Orthopaedics, Inc. Warsaw , IN 56481 |
Approval for the following changes to the existing LCS Complete RPS Femoral Components: 1) changes to include minor dimensional and tolerance changes; 2) the description of the device will change to LCS Complete RPS Flexion; and 3) additional labeling for use in patients requiring a higher than normal degree of flexion. |
| P860047/S020 3/24/08 180-Day |
Ocucoat® (2% Hydroxypropyl-methylcellulose Solutions) | Bausch & Lomb, Inc. San Dimas , CA 91773 |
Approval for a change to the primary container of Ocucoat®, packaging and method of sterilization. |
| P890003/S131 3/17/08 180-Day |
Medtronic® 2490C CareLink Monitor 2020A CardioSight® Reader 2491 Device Data Management Application (DDMA)
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Medtronic, Inc. Mounds View, MN 55112 | Approval for removal of the contraindication: “Patients whose primary disorder is bradyarrhythmia” and for the Medtronic® Consulta ™ CRT-D D224TRK, Maximo® II CRT-D D284TRK Medtronic® Secura™ DR D224DRG, Medtronic® Secura™ VR D224VRC, Maximo® II DR D284DRG, Maximo® II VR D284VRC , Model 9995 Application Software Version 1.1 Systems, Medtronic® 2490C CareLink Monitor, 2020A CardioSight® Reader and 2491 Device Data Management Application (DDMA). The device, as modified, will be marketed under the trade name: Medtronic® Consulta ™ CRT-D D224TRK, Maximo® II CRT-D D284TRK Medtronic® Secura™ DR D224DRG, Medtronic® Secura™ VR D224VRC, Maximo® II DR D284VRC, Maximo® II VR D284DRG Medtronic® 2490C CareLink Monitor, 2020A CardioSight® Reader and 2491 Device Data Management Application (DDMA) and is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. In addition, the device is indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction < 35% and a prolonged QRS duration. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP) and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication. |
| P890040/S006 3/3/08 135-Day |
Sof-Form 55 EW and LL-55 Soft Hydrophilic Spherical Contact Lenses | Unilens Corporation, U.S.A. Largo , FL 33777 |
Approval to begin parametric release for hydrophilic lenses packaged in vials. |
| P900022/S010 3/18/08 Real-Time |
All Non-Rate Responsive Implantable Pacemakers | ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the SmartView 2.02 UG3 Software. The software modifications are intended to make minor software corrections and to add the PaceArt XML converter to the SmartView 2.02 UG2 software. |
| P910023/S150 3/17/08 180-Day |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for Merlin@home DM EX 1200 Transmitter with Software EX 2000. |
| P910023/S168 3/6/08 Real-Time |
Cadence Family of ICD’s | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for minor modifications to the controller integrated circuit chips used in the Current ICD and Promote CRT-D devices. |
| P910023/S169 3/11/08 Special |
Cadence Family of ICD’s | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the addition of a manufacturing inspection step to verify battery pin placement. |
| P910077/S084 3/17/08 Real-Time |
Latitude™ Communicator Software & System Software | Boston Scientific Corporation St. Paul , MN 55112 |
Approval for the LATITUDE PACEART Integration® (LPI) (Model 6472 v1.0) that will reside on the LATITUDE Patient Management System (Model 6488 v4.0). |
| P930014/S023 3/11/08 Real-Time |
AcrySof® Intraocular Lenses (IOL) | Alcon Research, LTD Fort Worth , TX 76134 |
Approval for design modifications to the AcrySof® Intraocular Lens (IOL) case. |
| P930038/S054 03/18/09 Real-Time |
Angio-Seal Evolution Vascular Closure Device | St. Jude Medical Cardiovascular Division Maple Grove, MN 55311 |
Approval for device modifications to the Angio-Seal™ VIP Vascular Closure Device including utilizing an automated collagen compaction mechanism for ease of use. The device, as modified, will be marketed under the trade name Angio-Seal Evolution Vascular Closure Device and is indicated for use in closing and in reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography or percutaneous transluminal coronary angioplasty (PTCA) procedures using an 8 French or smaller procedural sheath. |
| P950029/S034 3/18/08 Real-Time |
All Rate Responsive Implantable Pacemakers | ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the SmartView 2.02 UG3 Software. The software modifications are intended to make minor software corrections and to add the PaceArt XML converter to the SmartView 2.02 UG2 software. |
| P960030/S020 3/18/08 Real-Time |
IsoFlex Optim Lead Models 1944 and 1948 | St. Jude Medical Cardiac Rhythm Management Division Slymar , CA 91342 |
Approval for device modifications to the IsoFlex Optim family of leads. The devices, as modified, will be marketed under the trade names IsoFlex Optim Model 1944T and IsoFlex Optim 1948T. |
| P960039/S003 3/3/08 135-Day |
Soft-55 EW Aphakic (vifilcon A) Soft Hydrophilic Spherical Contact Lenses | Unilens Corporation, U.S.A. Largo , FL 33777 |
Approval to begin parametric release for hydrophilic lenses packaged in vials. |
| P970008/S035 3/7/08 Real-Time |
Urologix Targis™ System for the Treatment of BPH | Urologix, inc. Minneapolis , MN 55447 | Approval for component changes to the microwave generator subassembly used in the Targis System Control Unit Model 4000 and in the CoolWave Control Unit Model 5000. |
| P970008/S036 3/31/08 Real-Time |
Urologix Targis™ System for the Treatment of BPH | Urologix, inc. Minneapolis , MN 55447 | Approval for changes to the materials, color, antenna design, coolant path functions and design of the Cooled ThermoCath catheter. The device, as modified, will be marketed under the trade name CTC Advance™ and is indicated to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethra lengths of 3.5 – 5.0 cm (model number TC1121C) or 4.5+ cm (model number TF1221C). |
| P970008/S037 3/10/08 Real-Time |
Urologix Targis™ System | Urologix, inc. Minneapolis , MN 55447 | Approval for modifications to improve system airflow and to improve regulation of the power supply. |
| P970038/S011 3/6/08 Real-Time |
Access® Hybritech® free PSA Reagents on the Access® Immunoassay Analyzer | Beckman Coulter, Inc. Chaska , MN 55318 |
Approval for a reformulated wash buffer, Wash Buffer II on the Access® Immunoassay Systems. |
| P980016/S114 3/17/08 180-Day |
Medtronic® Secura™ DR D224DRG Medtronic® Secura™ VR D224VRC Maximo® II DR D284DRG Maximo® II VR D284VRC
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Medtronic, Inc. Mounds View, MN 55112 |
Approval for removal of the contraindication: “Patients whose primary disorder is bradyarrhythmia” and for the Medtronic® Consulta ™ CRT-D D224TRK, Maximo® II CRT-D D284TRK Medtronic® Secura™ DR D224DRG, Medtronic® Secura™ VR D224VRC, Maximo® II DR D284DRG, Maximo® II VR D284VRC, Model 9995 Application Software Version 1.1 Systems, Medtronic® 2490C CareLink Monitor, 2020A CardioSight® Reader and 2491 Device Data Management Application (DDMA). The device, as modified, will be marketed under the trade name: Medtronic® Consulta ™ CRT-D D224TRK, Maximo® II CRT-D D284TRK Medtronic® Secura™ DR D224DRG, Medtronic® Secura™ VR D224VRC, Maximo® II DR D284VRC, Maximo® II VR D284DRG Medtronic® 2490C CareLink Monitor, 2020A CardioSight® Reader and 2491 Device Data Management Application (DDMA) and is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. In addition, the device is indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction < 35% and a prolonged QRS duration. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP) and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication. |
| P980037/S025 3/28/08 Real-Time |
AngioJet® Rheolytic™ Thrombectomy System – Spiroflex® VG Thrombectomy Set | Possis Medical, Inc. Minneapolis , MN 55433 | Approval for the Spiroflex® VG Thrombectomy Set. |
| P980041/S011 3/26/08 Special |
Access® AFP Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc. Chaska , MN 55318 |
Approval for the addition of a warning regarding the concentration of ProClin 300 in the Access® AFP Sample diluent in the product labeling. |
| P980049/S035 3/18/08 Real-Time |
All Implantable Cardioverter Defibrillators | ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the SmartView 2.02 UG3 Software. The software modifications are intended to make minor software corrections and to add the PaceArt XML converter to the SmartView 2.02 UG2 software. |
| P990052/S019 3/25/08 Real-Time |
Vibrant Soundbridge Middle Ear Implant System | Vibrant Med-EL Hearing Technology Durham , NC 27713 |
Approval for a minor software change to the currently approved SYMFIT module and is indicated for adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids. |
| P000009/S024 3/11/08 180-Day |
Lexos ICDs, Lumos ICDs, and Xelos DR-T ICD | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for a change in the chemical formulation of the manganese binding agent used in the construction of batteries to PTFE dispersion Dyneon TF 5032 R. |
| P000009/S025 3/10/08 Real-Time |
Lumos VR/DR (-T) and Lexos DR/VR (-T) ICDs | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for changes to: 1) Geometrical dimensions of the flange of the feedthrough; and 2) Insulating glass type 8455 has been replaced by glass type 8250. |
| P000020/S011 3/13/08 Real-Time |
Scorpion / Scorpion M Ablation Catheter | C. R. Bard, Inc. Lowell , MA 01851 |
Approval for the addition of a catheter with a tabbed thumbwheel. |
| P000021/S012 3/14/08 Special |
Dimension® TPSA Flex® Regent Cartridge | Siemens Corp. Newark , DE 19714 |
Approval for the following changes to the product Instructions for Use: 1) Add a new section titled Risk and Safety to provide additional safety information about the preservatives present in some of the product reagents; 2) Add information under the section titled Precautions on the presence of sodium azide, along with hazard and disposal information; and 3) Provide for reference only additional UFU changes being implemented concurrently with the safety information. |
| P000025/S026 3/14/08 180-Day |
COMBI 40+ Cochlear Implant System | Med-El Corporation Durham , NC 27713 |
Approval for the DaCapo system which is an alternative rechargeable battery pack to power the behind-the-ear speech processor, an external component of the COMBI 40+ Cochlear Implant System. |
| P000029/S017 3/28/08 180-Day |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Approval for a manufacturing site located at Q-Med AB, Uppsala, Sweden, to test for heavy metals and analysis of nitrates. |
| P000029/S034 3/20/08 135-Day |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Approval for a site change for an in process test for the device. |
| P000032/S022 3/21/08 135-Day |
Her Option™ Cryoablation Therapy System | American Medical Systems Minnetonka , MN 55343 |
Approval for a proposed change to eliminate the post sterile audit test process for the Her Option™ Cryoablation System disposable probe. |
| P000054/S016 3/17/08 180-Day |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis , TN 38136 |
Approval for inclusion of a warning related to localized, transient bone resorption in the package insert. The inclusion of this additional warning was prompted by a labeling modification required by the EU as a result of an analysis of reported adverse events. |
| P000058/S027 3/21/08 180-Day |
Infuse® Bone Graft | Medtronic Sofamor Danek Memphis , TN 38136 |
Approval for the following modifications to the package insert: 1) inclusion of warnings related to localized, transient bone resorption and possible nerve compression due to ectopic bone formation prompted by a labeling modification required by the EU as a result of an analysis of reported adverse events; 2) inclusion of clinical and adverse event data resulting from the clinical post approval study; 3) inclusion of a warning related to adverse events potentially associated with over stuffing the scaffold component into a small volume or hyperconcentrating the recombinant human protein component; 4) inclusion of references to previously approved XS and XXS kits; and 5) strengthening the language stating that the components of the product may only be used together and not with other devices or components, e.g., scaffolds other than the ACS. |
| P010012S037 3/13/08 Panel |
Contak Renewal® 3 AVT System and Contak Renewal® 3 AVT HE System | Guidant Corporation St. Paul , MN 55112 |
Approval for the Contak Renewal® 3 AVT and Contak Renewal® 3 AVT HE Systems. The systems are indicated for the following: CONTAK RENEWAL 3 AVT Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF £ 35%) and QRS duration ³ 120 ms . CONTAK RENEWAL 3 AVT provides atrial antitachycardia pacing and atrial defibrillation treatment for patients with a history of or who are at risk of developing atrial arrhythmias. |
| P010012/S175 3/17/08 Real-Time |
System Software Model 2909 v6.02 | Boston Scientific Corporation St. Paul , MN 55112 |
Approval for the System Software Model 2909 v6.02 with the Programmer Model 3120 and the Model 2893 application software for the CONTAK RENEWAL 3 AVT pulse generators (Models M150, M155, M157 and M159). |
| P010031/S084 3/17/08 180-Day |
Medtronic® Consulta™ CRT-D D224TRK and Maximo® II CRT-D D284TRK | Medtronic, Inc. Mounds View, MN 55112 |
Approval for removal of the contraindication: “Patients whose primary disorder is bradyarrhythmia” and for the Medtronic® Consulta ™ CRT-D D224TRK, Maximo® II CRT-D D284TRK Medtronic® Secura™ DR D224DRG, Medtronic® Secura™ VR D224VRC, Maximo® II DR D284DRG, Maximo® II VR D284VRC, Model 9995 Application Software Version 1.1 Systems, Medtronic® 2490C CareLink Monitor, 2020A CardioSight® Reader and 2491 Device Data Management Application (DDMA). The device, as modified, will be marketed under the trade name: Medtronic® Consulta ™ CRT-D D224TRK, Maximo® II CRT-D D284TRK Medtronic® Secura™ DR D224DRG, Medtronic® Secura™ VR D224VRC, Maximo® II DR D284VRC, Maximo® II VR D284DRG Medtronic® 2490C CareLink Monitor, 2020A CardioSight® Reader and 2491 Device Data Management Application (DDMA) and is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. In addition, the device is indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction < 35% and a prolonged QRS duration. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP) and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication. |
| P010032/S023 3/28/08 180-Day | Eon mini IPG Neurostimulation System (Model 3788) | Advanced Neuromodulation Systems, Inc. Plano , TX 75024 |
Approval for the Eon mini IPG Neurostimulation System (Model 3788), which is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. |
| P020001/S005 3/12/08 Real-Time |
STAN S31 Fetal Heart Monitor | Neoventa Medical AB Alexandria , VA 22314 |
Approval for a change to the Patient Interface Box and Cables. |
| P020027/S008 3/14/08 Special |
Dimension® FPSA Flex® Regent Cartridge | Siemens Corp. Newark , DE 19714 |
Approval for the following changes to the product Instructions for Use: 1) Add a new section titled Risk and Safety to provide additional safety information about the preservatives present in some of the product reagents; 2) Add information under the section titled Precautions on the presence of sodium azide, along with hazard and disposal information; and 3) Provide for reference only additional UFU changes being implemented concurrently with the safety information. |
| P020056/S004 3/20/08 180-Day |
Natrelle™ Silicone-Filled Breast Implants | Allergan Santa Barbara , CA 93111 |
Approval of the addition of the shell fabrication/dipping production to the manufacturing site located in Heredia Costa Rica. |
| P030005/S050 3/18/08 Real-Time |
Contak Renewal TR/TR2 Devices, Models H120 and H125 | Boston Scientific Corporation, CRM St. Paul , MN 5112 |
Approval for an alternate supplier for the surge suppressor for the devices. |
| P030053/S005 3/5/08 180-Day |
MemoryGel™ Silicone Gel- Filled Breast Implants |
Mentor Corporation Santa Barbara , CA 93111 |
Approval for an alternative spray method for manufacturing the shell component of the MemoryGel™ Silicone Gel- Filled Breast Implants. |
| P030054/S063 3/17/08 180-Day |
Epic HF/Atlas+HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for Merlin@home DM EX 1200 Transmitter with Software EX 2000. |
| P030054/S081 3/6/08 Real-Time |
Epic HF/Alas+ HF Family of CRT-D’s | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for minor modifications to the controller integrated circuit chips used in the Current ICD and Promote CRT-D devices. |
| P030054/S082 3/11/08 Special |
Epic HF/Alas+ HF Family of CRT-D’s | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the addition of a manufacturing inspection step to verify battery pin placement. |
| P040002/S014 3/5/08 Real-Time |
Endologix PowerLink® System with Visiflex with SurePass Delivery Catheter System | Endologix, Inc. Irvine , CA 92618 |
Approval for the removal of the steel hypotube from the 21Fr bifurcated delivery system, the 17Fr straight delivery system, and the 19Fr delivery system. |
| P040002/S015 3/21/08 Real-Time |
Endologix PowerLink® System with Visiflex with SurePass Delivery Catheter System | Endologix, Inc. Irvine , CA 92618 |
Approval for two new limb extension accessories, the tapered limb extension and the stepped limb extension. |
| P040020/S008 3/11/08 Real-Time |
AcrySof® Intraocular Lenses (IOL) | Alcon Research, LTD Fort Worth , TX 76134 |
Approval for design modifications to the AcrySof® Intraocular Lens (IOL) case. |
| P040044/S006 3/27/08 Special |
Mynx™ Vascular Closure Device | AccessClosure, Inc. Mountain View , CA 94043 |
Approval for minor changes to the Instructions for Use (IFU) for the Mynx™ Vascular Closure Device. |
| P040045/S002 3/31/08 180-Day |
Vistakon® (senofilcon A) Contact Lenses for Extended Wear | Vistakon® Division of Johnson & Johnson Vision Care, Inc. Jacksonville , FL 32256 |
Approval for an alternate manufacturing site located at Johnson & Johnson ( Ireland) Ltd., Limerick, Ireland. |
| P050023/S008 3/11/08 180-Day |
Lexos ICDs and Lumax ICDs & CRT-Ds | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for a change in the chemical formulation of the manganese binding agent used in the construction of batteries to PTFE dispersion Dyneon TF 5032 R. |
| P050023/S009 3/10/08 Real-Time |
Lumax VR/DR/HF (-T) ICDs and CRT-Ds | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for changes to: 1) Geometrical dimensions of the flange of the feedthrough; and 2) Insulating glass type 8455 has been replaced by glass type 8250. |
| P050024/S001 3/13/08 180-Day |
CryoCor Cardiac Cryoablation System | Cryocor, Inc. San Diego , CA 92121 |
Approval of the post-approval study. |
| P050046/S002 3/5/08 Real-Time |
Acuity Steerable Lead Models 4554, 4555, 4556 | Boston Scientific Guidant Corporation St. Paul , MN 55112 |
Approval for a specification change for acceptance of silicone tubing used to manufacture Acuity Steerable Leads. |
| P050053/S001 3/6/08 180-Day |
InFuse® Bone Graft |
Medtronic Sofamor Danek 38132 |
Approval for the addition of the XS and XXS InFuse Bone Graft kits to the approved dental bone grafting material. |
| P060002/S001 3/13/08 180-Day |
FLAIR™ Endovascular Stent Graft | C.R. Bard, Inc. Tempe , AZ 85281 |
Approval of the post-approval study. |
30-Day Notices (135 Day Supplement was not required)
| P840001/S106 3/26/08 | Synergy and Prime Families of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis , MN 55432 | Change to the workstation used to weld the case-to-cover seam joint on medium rate batteries. |
| P860004/S096 3/26/08 | SynchroMed II Implantable Infusion Pump | Medtronic Neuromodulation Minneapolis , MN 55432 | Change to the workstation used to weld the case-to-cover seam joint on medium rate batteries. |
| P910023/S167 3/6/08 | Cadence Family of Implantable Cardioverter Defibrillators | St. Jude Medical Cardiac Rhythm Management Division | Alternate suppliers for two components. |
| P950020/S026 3/20/08 | Flextome™ Cutting Balloon™ Monorail (MR), Flextome™ Cutting Baloon Over-the-Wire (OTW), Cutting Balloon Ultra 2 MR, and Cutting Balloon Ultra 2 OTW | Boston Scientific San Diego, CA 92123 | Changes to the bioburden sampling plans. |
| P960009/S046 3/26/08 | Kinetra Neurostimulator | Medtronic Neuromodulation Minneapolis , MN 55432 | Change to the workstation used to weld the case-to-cover seam joint on medium rate batteries. |
| P960040/S161 3/21/08 | Confient Tachy Pulse Generators | Guidant Corporation St. Paul , MN 55112 |
Additional product to be processed on existing manufacturing equipment. |
| P960040/S162 3/26/08 | Prizm2/Vitality & Confient/Livian Family of Devices | Guidant Corporation St. Paul , MN 55112 |
Adding an additional supplier of components. |
| P970004/S048 3/26/08 | Interstim Neurostimulator | Medtronic Neuromodulation Minneapolis , MN 55432 |
Change to the workstation used to weld the case-to-cover seam joint on medium rate batteries. |
|
P980035/S087 3/26/08 |
EnRhythm IPG | Medtronic, Inc. Shoreview , MN 55126 |
Change to the workstation used to weld the case-to-cover seam joint on medium rate batteries. |
| P980049/S030 3/20/08 |
Ovatio VR & DR ICDs | ELA Medical, Inc./ Sorin Group Plymouth , MN 55441 |
Change for the KMOS (T267), the integrated circuit, rework process. |
| P980049/S031 3/20/08 |
Ovatio VR 6250 and Ovatio DR 6550 | ELA Medical, Inc. Plymouth, MN 55441 | Adding a second supplier for hybrid modules used in the manufacture of the device. |
| P980049/S032 3/20/08 | Ovatio VR & DR ICDs | ELA Medical, Inc./ Sorin Group Plymouth , MN 55441 |
Change in the cutting hybrid pads manufacturing procedure. |
| P980049/S033 3/20/08 | Ovatio VR 6250 and Ovatio DR 6550 | ELA Medical, Inc. Plymouth, MN 55441 |
Change involving the gluing process between the cap and the connector of the device. |
| P990009/S022 3/20/08 | Floseal Hemostatic Matrix 5ml Kit | Baxter Healthcare Corporation McGaw Park , IL 60085 |
Replacement of an existing thrombin component envelope with a thrombin component tray. |
| P990013/S015 3/21/08 | Collamer UV-Absorbing Posterior Chamber Intraocular Lens | STAAR Surgical Monrovia , CA 91016 |
Implementation of new semi-automated production equipment for the Blocking process. |
| P000021/S011 3/13/08 | Dimension® TPSA Flex® Reagent Cartridge | Siemens Corp. Newark , DE 19714 |
Change to the Flex® assembly Machine production line number 4 to allow production of the LOCI chemistries on this production line. |
| P000029/S037 3/7/08 | Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Modifications to the manufacturing facility (clean room) and equipment upgrades. |
| P000029/S039 3/11/08 | Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton , NJ 08540 | Change to the control system review frequency and the use of compressed air in the water system. |
| P000039/S025 3/5/08 | Amplatzer Septal Occluder and Amplatzer Multi-Fenestrated Septal Occluder – “Cribriform” | AGA Medical Corporation Plymouth , MN 55442 |
Modification of the Tyvek pouch sealing parameters. |
| P010012/S173 3/21/08 | Livian and Renewal RF Heart Failure Pulse Generators | Guidant Corporation St. Paul , MN 55112 |
Additional product to be processed on existing manufacturing equipment. |
| P010012/S174 3/26/08 |
Contact Renewal Family of Devices | Guidant Corporation St. Paul , MN 55112 |
Adding an additional supplier of components. |
| P010015/S038 3/26/08 | InSync III CRT-P | Medtronic, Inc. Shoreview , MN 55126 |
Change to the workstation used to weld the case-to-cover seam joint on medium rate batteries. |
| P020024/S019 3/5/08 | Amplatzer Duct Occluder | AGA Medical Corporation Plymouth , MN 55442 | Modification of the Tyvek pouch sealing parameters. |
| P020027/S007 3/13/08 | Dimension® FPSA Flex® Reagent Cartridge | Siemens Corp. Newark , DE 19714 |
Change to the Flex® assembly Machine production line number 4 to allow production of the LOCI chemistries on this production line. |
| P030016/S003 3/26/08 | STAAR Visian ICL™ | STAAR Surgical Monrovia , CA 91016 | Changes to the Collamer lens blocking process. |
| P030017/S032 3/26/08 | Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Sylmar , CA 91342 |
Addition to the Linear Leads inspection procedure. |
| P030017/S034 3/26/08 | Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Sylmar , CA 91342 |
Additional visual inspection step to the Insertion Needle inspection process. |
| P030026/S014 3/5/08 |
Vitros Immunodiagnostic Products anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products anti-HBc IgM Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Introduction of a new piece of automated equipment that replaces a manual assembly operation. |
| P030054/S080 3/6/08 | Epic HF Cardiac Resynchronization Therapy Devices | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Alternate suppliers for two components. |
| P040024/S017 3/7/08 | Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale , AZ 85258 | Elimination of high differential pressure warning limits for clean rooms use din the manufacture of the device. |
| P040027/S011 3/28/08 | GORE VIATORR TIPS Endoprosthesis | W.L. Gore & Associates Flagstaff , AZ 86003 | Discontinuance of the 100% in-process water entry pressure test for the graft component of the device. |
| P040037/S010 3/14/08 | GORE VIABAHN® Endoprosthesis | W.L. Gore & Associates Flagstaff , AZ 86003 | Use of an alternate model of bonding oven for attaching the stent to the graft to construct the endoprosthesis. |
| P040037/S011 3/20/08 | GORE VIABAHN® Endoprosthesis | W.L. Gore & Associates Flagstaff , AZ 86003 | Use of an alternate annealing oven rack and quench tank. |
| P040040/S004 3/5/08 | Amplatzer Muscular VSD Occluder | AGA Medical Corporation Plymouth , MN 55442 | Modification of the Tyvek pouch sealing parameters. |
| P040043/S022 3/13/08 | Gore® TAG Thoracis Endoprosthesis | W.L. Gore & Associates Flagstaff , AZ 86003 | Addition of an in-process inspection step utilizing an air leak detector. |
| P050045/S002 3/26/08 | TOP2A FISH pharmDx™ Kit | Dako Denmark A/S Glustrup , Denmark DK-2600 | Change in auxiliary material/supplier used in the production of the probe mix to eliminate enzyme related stability problems. |
| P070012/S001 3/6/08 | Medtronic Vascular Exponent Self-Expanding Carotid Stent System | Medtronic Vascular Santa Rose , CA 95403 | Change by the vendor of the Exponent RX packaging header pouch to the equipment used to produce the vendor-supplied seals. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 58
Summary of PMA Originals Under Review
Total Under Review: 75
Total Active: 37
Total On Hold: 38
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 483
Total Active: 322
Total On Hold: 161
Number Greater Than 180 Days: 13
Summary of All PMA Submissions Received
Originals: 4
Supplements: 177
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 58
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 122.3
FDA Time: 81.4 Days MFR Time: 40.9 Days
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