Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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.
| P060037 12/10/07 |
Zimmer NexGen® LPS-Flex Mobile and LPS-Mobile Bearing Knees | Zimmer, Inc. Warsaw, IN 46581 |
Approval for the Zimmer NexGen® LPS-Flex Mobile and LPS-Mobile Bearing Knees. These devices are indicated for patients with severe knee pain and disability due to osteoarthritis; primary and secondary traumatic arthritis; avascular necrosis of the femoral condyle; or moderate valgus, varus, or flexion deformities (i.e., valgus/varus deformity of ≤15 degrees, fixed flexion deformity of ≤10 degrees). This device is intended for cemented use only. |
| P070001 12/17/07 |
ProDisc™-C Total Disc Replacement | Synthes Spine, Inc. West Chester, PA 19380 |
Approval for the ProDisc™-C Total Disc Replacement. The device is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The ProDisc™-C Total Disc Replacement is implanted via an open anterior approach. Patients receiving the ProDisc™-C Total Disc Replacement should have failed at least six weeks of non-operative treatment prior to implantation of the ProDisc™-C Total Disc Replacement. |
| N18286/S017 12/13/07 180-Day |
Gelfoam Plus Hemostasis Kit | Pfizer, Inc. New York, NY 10017 |
Approval for a new kit configuration to include human thrombin. The kit is to be prepared at the Baxter Healthcare Corporation plant in Hayward, California. The device, as modified, will be marketed under the trade name Gelfoam Plus Hemostasis Kit and is intended as a hemostatic device for surgical procedures when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. |
| P840068/S046 12/20/07 180-Day |
Delta/Vista and Vigor | Boston Scientific/ Guidant Corporation St. Paul, MN 55112 |
Approval to update the System Software Model 2909 from v4.4 to v6.0 for the run time environment of the Model 3120 PRM. |
| P860004/S091 12/19/07 Special |
SynchroMed Implantable Infusion Pumps | Medtronic Neurological Minneapolis, MN 55432 |
Approval for proposed labeling changes that address inflammatory mass formation. |
| P880006/S055 12/12/07 Real-Time |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for two corrective fixes to address a hardware issued that can leave the CRT-D and ICD systems listed above in a post-sense refractory state. For devices that are already implanted and/or already manufactured, changes will be made to the programmer software. During a patient follow-up visit, the programmer will interrogate the device and download firmware RAM code to correct the anomalous condition if it occurs. For new devices, a modification has been made to the SIO2 chip hardware to check the sense refractory state every two seconds and end it if appropriate. |
| P880086/S156 12/12/07 Real-Time |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for two corrective fixes to address a hardware issued that can leave the CRT-D and ICD systems listed above in a post-sense refractory state. For devices that are already implanted and/or already manufactured, changes will be made to the programmer software. During a patient follow-up visit, the programmer will interrogate the device and download firmware RAM code to correct the anomalous condition if it occurs. For new devices, a modification has been made to the SIO2 chip hardware to check the sense refractory state every two seconds and end it if appropriate. |
| P880091/S023 12/4/007 Real-Time |
Silicone Ultraviolet Absorbing Posterior Chamber Intraocular Lens (IOL) | STAAR Surgical Co. Monrovia, CA 91016 |
Approval for a change in the approved polycarbonate packaging material that is in direct contact with the lens during steam sterilization and throughout the shelf-life of the lens. |
| P900023/S047 12/11/07 180-Day |
i Pulse Circulatory Support System | ABIOMED, Inc. Danvers, MA 01923 |
Approval for the iPulse Circulatory Support System, a unit that will support patients in need of full circulatory support using the BVS 5000 blood pump or the AB5000 Ventricle, or partial ventricular assist using the approved intra-aortic balloon pump (IABP). The device console, as modified, will be marketed under the trade name iPulse Circulatory Support System and is indicated for use in conjunction with the ABIOMED® AB 5000™ ventricle and the BVS 5000® Blood Pump. |
| P900023/S048 12/21/07 180-Day |
AB5000 Circulatory Support System | Abiomed, Inc. Danvers, MA 01923 |
Approval for a labeling change to include a statement regarding additional in vitro reliability testing of the pump. |
| P910023/S160 12/7/07 Real-Time |
Merlin.net Software Version 2.5 | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for the Merlin.net version 2.5. It consists of the Matrix PCS release 2.5, which is the Housecall Receiver Software, version 4000-3.5.1 and the Receiver Manager Software. |
| P910023/S161 2/19/07 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for the following modifications: 1) replace the existing hand solder interconnections between subassemblies with plug/receptacle connectors; 2) an organic substrate will be used for the hybrid module; and 3) discrete surface mount magnetic components were re-configured into surface-mountable packages. |
| P910023/S162 12/12/07 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for two corrective fixes to address a hardware issued that can leave the CRT-D and ICD systems listed above in a post-sense refractory state. For devices that are already implanted and/or already manufactured, changes will be made to the programmer software. During a patient follow-up visit, the programmer will interrogate the device and download firmware RAM code to correct the anomalous condition if it occurs. For new devices, a modification has been made to the SIO2 chip hardware to check the sense refractory state every two seconds and end it if appropriate. |
| P910066/S024 12/10/07 Real-Time |
OL1000 Dual Coil Medium Bone Growth Stimulation Device | DJO, LLC Vista, CA 92081 |
Approval for the modification of the existing coil geometry, the addition of a wired control box, the reconfiguration of the patient padding system, and the removal of the infrared patient compliance component. The device, as modified, will be marketed under the trade name OL1000 Dual Coil Medium Bone Growth Stimulation Device and is indicated for the non-invasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. |
| P910071/S010 12/12/07 Real-Time |
ADATO® SIL-OL 5000 Silicone Oil | Bausch and Lomb, Inc. San Dimas, CA 91773 |
Approval for a packaging change which involves the addition of a rigid tip cap to the 10 cc glass syringe packaging configuration to incorporate a rigid polypropylene housing around the elastomer seal. |
| P910077/S076 12/20/07 180-Day |
Ventak Mini AICD | Boston Scientific/ Guidant Corporation St. Paul, MN 55112 |
Approval to update the System Software Model 2909 from v4.4 to v6.0 for the run time environment of the Model 3120 PRM. |
| P940031/S061 12/20/07 180-Day |
Pulsar/Pulsar Max/ Discovery/Meridian | Boston Scientific/ Guidant Corporation St. Paul, MN 55112 |
Approval to update the System Software Model 2909 from v4.4 to v6.0 for the run time environment of the Model 3120 PRM. |
| P950022/S046 12/21/07 125-Day |
Riata Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a change to the shock coil backfill manufacturing process. |
| P950037/S053 12/7/07 180-Day |
Cylos Pacemaker; Philos II Pacemakers; and Implant Module | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Application software version A-K00.10U of the PMS/TMS 1000, and Application software version 703.U/1 of the ICS 3000. |
| P950037/S055 12/7/07 Real-Time |
ICS 3000 Implant Control System | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for changes to the ICS 300 programmer head, technical manual, and the PGH Blue Foil label. |
| P960016/S020 12/19/07 Real-Time |
Safire™ Bidirectional Ablation Catheter | St. Jude Medical Atrial Fibrillation Division Minnetonka, MN 55345 |
Approval for minor design changes to the outer shell of the upper and lower handle components. |
| P960040/S148 12/20/07 180-Day |
Vitality AVT AICD, Ventak AV DDD, Ventak VR, Ventak AV DR, Ventak Prizm I/II/HE, Vitality OBDE, Contak CD2, Ventak Prizm AVT, Vitality, and Vitality HE | Boston Scientific/ Guidant Corporation St. Paul, MN 55112 |
Approval to update the System Software Model 2909 from v4.4 to v6.0 for the run time environment of the Model 3120 PRM. |
| P970003/S077 12/14/07 180-Day |
VNS Therapy System | Cyberonics Houston, TX 77058 |
Approval for a manufacturing site located at Cyberonics, Houston, Texas. |
| P970003/S090 12/20/07 180-Day |
VNS Therapy System | Cyberonics Houston, TX 77058 |
Approval for revisions to the post-approval study. |
| P970003/S091 12/20/07 180-Day |
VNS Therapy System | Cyberonics Houston, TX 77058 |
Approval for revisions to the post-approval study. |
| D970003/S091 12/20/07 180-Day |
Insignia, Pulsar Max II/Discovery II, and Pulsar/Pulsar Max/Discovery/ Meridian | Boston Scientific/ Guidant Corporation St. Paul, MN 55112 |
Approval to update the System Software Model 2909 from v4.4 to v6.0 for the run time environment of the Model 3120 PRM. |
| P970003/S093 12/21/07 Real-Time |
VNS Therapy™ System | Cyberonics, Inc. Houston, TX 77058 |
Approval for an alternate component to the Demipulse (Model 103) and Demipulse Duo (Model 104) Pulse Generators printed circuit board (PCB) assembly. |
| P970003/S095 12/19/07 Special |
VNS Therapy™ System | Cyberonics, Inc. Houston, TX 77058 |
Approval for changes consisting of adding “seroma” as an additional possible adverse event in the Epilepsy and Depression Information modules and adding a note describing possible risks with replacing a larger pulse generator with a smaller one in the Revision/ Replacement/ Removal module. |
| P970013/S022 12/12/07 Real-Time |
Microny Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for two corrective fixes to address a hardware issued that can leave the CRT-D and ICD systems listed above in a post-sense refractory state. For devices that are already implanted and/or already manufactured, changes will be made to the programmer software. During a patient follow-up visit, the programmer will interrogate the device and download firmware RAM code to correct the anomalous condition if it occurs. For new devices, a modification has been made to the SIO2 chip hardware to check the sense refractory state every two seconds and end it if appropriate. |
| P980016/S115 12/4/07 Real-Time |
Marquis DR/VR Models 7274, 7230B, 7230Cx, 7230E; Maximo DR/VR Models 7278, 7232B, 7232Cx, 7232E, Intrinsic 30/Intrinsic Models 7287, 7288; EnTrust D153TG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC; Virtuoso D154AWG, D154VWC | Medtronic, Inc. Moundsview, MN 55112 |
Approval for minor design changes that add two alternate tantalum capacitors (XTC017, XTC018) with increased voltage ratings to approved device components. The design modifications are intended to reduce manufacturing yield loss and associated rework . |
| P980023/S029 12/7/07 180-Day |
Cardiac Airbag (-T) ICDs; and Belos VR (-T) ICDs | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Application software version A-K00.10U of the PMS/TMS 1000, and Application software version 703.U/1 of the ICS 3000. |
| P980035/S081 12/4/07 Real-Time |
EnRhythm P1501DR | Medtronic, Inc. Moundsview, MN 55112 |
Approval for minor design changes that add two alternate tantalum capacitors (XTC017, XTC018) with increased voltage ratings to approved device components. The design modifications are intended to reduce manufacturing yield loss and associated rework . |
| P980043/S015 12/12/07 Special |
HANCOCK® II Porcine Bioprosthesis, Models T505, T510 | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval for the addition of a caution statement to the labeling. |
| P990004/S012 12/13/07 180-Day |
Surgifoam Absorbable Gelatin Sponge, U.S.P. | Johnson & Johnson Wound Management a Division of Ethicon, Inc. Somerville, NJ 08876 |
Approval for the addition of clinical results to the product labeling with an update to the directions for use to allow use in endoscopic nasal sinus surgery and addition of a bendable applicator tip (FlexTip). The device, as modified, will be marketed under the trade name Surgifoam Absorbable Gelatin Sponge, U.S.P. and is indicated for an adjunct to hemostasis during surgical procedures. |
| P990004/S013 12/27/07 180-Day |
Surgifoam Absorbable Gelatin Sponge, U.S.P., Surgifoam Absorbable Gelatin Powder, & Surgiflo Hemostatic Matrix | Johnson & Johnson Wound Management Worldwide Somerville, NJ 08876 |
Approval for the removal of the urologic procedures exclusion from the indications statement. |
| P990020/S028 12/6/07 Real-Time |
AneuRx AAAdvantage Xcelerant Hydro Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the addition of a hydrophilic coating to the device. |
| P990034/S010 12/19/07 Special |
SynchroMed IsoMed Implantable Infusion Pumps | Medtronic Neurological Minneapolis, MN 55432 |
Approval for proposed labeling changes that address inflammatory mass formation. |
| P990046/S016 12/11/07 180-Day |
ATS Open Pivot™ Bileaflet Heart Valve Models AP360 | ATS Medical, Inc. Minneapolis, MN 55447 |
Approval for the ATS Open Pivot™ Bileaflet Heart Valve Models AP360. |
| P990064/S022 12/12/07 Special |
Mosaic® Porcine Bioprosthesis, Models 305, 310 | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval for the addition of a caution statement to the labeling. |
| P000009/S022 12/7/07 180-Day |
Lexos DR/VR (-T) ICDs; Lumos VR/DR (-R); Xelos DR-T ICD; and Belos VR (-T) ICD |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Application software version A-K00.10U of the PMS/TMS 1000, and Application software version 703.U/1 of the ICS 3000. |
| P000015/S010 12/31/07 Real-Time |
Nucleus 24 Auditory Brainstem Implant System | Cochlear Americas Englewood, CO 80112 |
Approval for use of Custom Sound 2.0 and the Freedom Sound Processor in recipients of the Nucleus Auditory Brainstem Implant. |
| P000039/S023 12/4/07 |
AMPLATZER® Septal Occluder and Multi-Fenestrated Septal Occluder (Cribriform) | AGA Medical Corporation Plymouth, MN 55442 |
Approval for AGA Medical Corporation to become the primary source for the laser welding process, while retaining the current vendor as a secondary source. |
| P000054/S009 12/21/07 180-Day |
InFuse™ Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for changes to the package insert and kit box text based on reports associated with several types of AEs. These AEs were the presence of fluid-filled cysts or radiographic evidence of peri-implant transient bone resorption. It’s believed that overpacking of the ACS component within a confined space and/or hyperconcentrating the rhBMP-2 solution were responsible for the AEs. |
| P000058/S020 12/21/07 180-Day |
InFuse™ Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for changes to the package insert and kit box text based on reports associated with several types of AEs. These AEs were the presence of fluid-filled cysts or radiographic evidence of peri-implant transient bone resorption. It’s believed that overpacking of the ACS component within a confined space and/or hyperconcentrating the rhBMP-2 solution were responsible for the AEs. |
| P000058/S022 12/20/07 180-Day |
InFuse™ Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for adding XS and XXS InFuse Bone Graft kits to the product lineup. |
| P010012/S155 12/20/07 180-Day |
Contak Renewal and Contak CD | Boston Scientific/ Guidant Corporation St. Paul, MN 55112 |
Approval to update the System Software Model 2909 from v4.4 to v6.0 for the run time environment of the Model 3120 PRM. |
| P010031/S085 12/4/07 Real-Time |
InSync II Marquis Model 7289; InSync III Marquis Model 7279; InSync II Protect Model 7295; InSync Maximo 7303, 7304; InSync Sentry 7297, 7299; and Concerto C154DWK and C164AWK | Medtronic, Inc. Moundsview, MN 55112 |
Approval for minor design changes that add two alternate tantalum capacitors (XTC017, XTC018) with increased voltage ratings to approved device components. The design modifications are intended to reduce manufacturing yield loss and associated rework . |
| P010032/S019 12/13/07 180-Day |
Genesis RC and the Eon Neurostimulation Systems | Advanced Neuromodulation Systems Plano, TX 75024 |
Approval for increasing the battery longevity claim for seven years to 10 years. |
| P010032/S021 12/10/07 180-Day |
ANS Eon C (IPG) Neuromodulation System Model 3688 | Advanced Neuromodulation Systems Plano, TX 75024 |
Approval for the use of the ANS Eon C (IPG) Neuromodulation System, model 3688 which is indicated as an aid in the management of chronic pain of the trunk and/or limb, including unilateral and bilateral pain associated with any of the following: failed back surgery syndrome, and intractable low back and leg pain. |
| P020022/S006 12/14/07 180-Day |
VERSANT® HCV RNA | Siemens Medical Solutions Diagnostics Berkeley, CA 94702 |
Approval for the addition of the VERSANT® 440 Molecular System (System 400). The device, as modified, will be marketed under the trade name VERSANT® HCV RNA and is indicated for: The VERSANT® HCV RNA 3.0 Assay (bDNA) is a signal amplification nucleic acid probe assay for the direct quantitation of human hepatitis C viral RNA (HCV RNA) in the serum or plasma of HCV infected individuals using the System 340 bDNA Analyzer or the VERSANT® 440 Molecular System. Specimens containing HCV genotypes 1-6 have been validated for quantitation in the assay. The VERSANT® HCV RNA 3.0 Assay (bDNA) is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and is useful in predicting non-sustained virological response to HCV therapy. The results from the VERSANT® HCV RNA 3.0 Assay (bDNA) must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established only for individuals treated with interferon alfa-2b plus ribavirin. No information is available on the assay’s predictive values when other therapies are used. |
| P020024/S017 12/4/07 |
AMPLATZER® Duct Occluder | AGA Medical Corporation Plymouth, MN 55442 |
Approval for AGA Medical Corporation to become the primary source for the laser welding process, while retaining the current vendor as a secondary source. |
| P030002/S013 12/12/07 Real-Time |
Eyeonics crystalens™ Model AT-45 Accommodating Intraocular Lens (IOL) | Eyeonics, Inc. Aliso Viejo, CA 92656 |
Approval for inclusion of the MicroSTAAR MSI-PR and MSI-TR injectors and MTC-60c cartridge in the Physician Labeling for the crystalens™ Models AT-50SE and AT-52SE. |
| P030005/S046 12/20/07 180-Day |
Contak Renewal TR | Boston Scientific/ Guidant Corporation St. Paul, MN 55112 |
Approval to update the System Software Model 2909 from v4.4 to v6.0 for the run time environment of the Model 3120 PRM. |
| P030035/S037 12/12/07 Real-Time |
Frontier and Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for two corrective fixes to address a hardware issued that can leave the CRT-D and ICD systems listed above in a post-sense refractory state. For devices that are already implanted and/or already manufactured, changes will be made to the programmer software. During a patient follow-up visit, the programmer will interrogate the device and download firmware RAM code to correct the anomalous condition if it occurs. For new devices, a modification has been made to the SIO2 chip hardware to check the sense refractory state every two seconds and end it if appropriate. |
| P030054/S073 2/19/07 Real-Time |
Epic HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for the following modifications: 1) replace the existing hand solder interconnections between subassemblies with plug/receptacle connectors; 2) an organic substrate will be used for the hybrid module; and 3) discrete surface mount magnetic components were re-configured into surface-mountable packages. |
| P030054/S074 12/12/07 Real-Time |
Epic HF/Atlas Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for two corrective fixes to address a hardware issued that can leave the CRT-D and ICD systems listed above in a post-sense refractory state. For devices that are already implanted and/or already manufactured, changes will be made to the programmer software. During a patient follow-up visit, the programmer will interrogate the device and download firmware RAM code to correct the anomalous condition if it occurs. For new devices, a modification has been made to the SIO2 chip hardware to check the sense refractory state every two seconds and end it if appropriate. |
| P040001/S008 12/14/07 180-Day |
X STOP® Interspinous Process Decompression System | Kyphon, Inc. Sunnyvale, CA 94089 |
Approval for a manufacturing site located at Kyphon, Inc., Sunnyvale, California, for inspection, packaging and final acceptance. |
| P040044/S004 12/17/07 Special |
Mynx™ Vascular Closure Device | AccessClosure, Inc. Mountain View, CA 94043 |
Approval for an additional inspection step in the manufacturing and testing process for the device. |
| P040052/S001 12/14/07 180-Day |
MonoPrep® Pap Test | MonoGen, Inc. Lincolnshire, IL 60069 |
Approval of the post-approval study. |
| P050023/S006 12/7/07 180-Day |
Kronos LV-T CRT-D; Lumax VR/DR/HF (-T) ICD and CRT-Ds |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Application software version A-K00.10U of the PMS/TMS 1000, and Application software version 703.U/1 of the ICS 3000. |
| P050025/S007 12/20/07 Special |
Boston Scientific NexStent® | Boston Scientific San Diego, CA 92123 |
Approval for a labeling clarification for “Arrythmia”, the addition of “Stent Fracture” to the list of potential adverse events, and clarifications to the labeling to clarify complete removal of the delivery system tracking tip from guide heath or guide catheter when removing the device under fluoroscopy (items 11, 12, and 17 or Table 1). |
| P050042/S003 12/10/07 Real-Time |
ARCHITECT® Anti-HCV, ARCHITECT® Anti-HCV Calibrator and ARCHITECT® Anti-HCV Control | Abbott Laboratories Abbott Park, IL 60064 |
Approval for changes to the output of the assay file interpretation screen. |
| P050044/S002 12/17/07 180-Day |
Vitagel Surgical Hemostat | Orthovita, Inc. Malvern, PA 19355 |
Approval for a contract sterilization facility located at Sterigenics International, San Diego, California. |
| P050044/S003 12/17/07 180-Day |
Vitagel Surgical Hemostat | Orthovita, Inc. Malvern, PA 19355 |
Approval for a contract testing facility located at LexaMed, Toledo, Ohio. |
| P050049/S002 12/19/07 Special |
Abbott AxSYM HBsAg Assay and AxSYM HBsAg Confirmatory Assays | Abbott Laboratories Abbott Park, IL 60064 |
Approval for labeling modifications that clarifies the meaning of the final interpretation repeat reactive, nonconforming for HBsAg in the AxSYM HBsAg Confirmatory package insert. Also, changes to the AxSYM HBsAg package insert to align with the removal of the term “repeat reactive” from the interpretation of results for the AxSYM HBsAg Confirmatory assays. |
| P050051/S002 12/5/07 Real-Time |
ARCHITECT® AUSAB® Reagent Kit, ARCHITECT® AUSAB® Calibrators, and ARCHITECT® AUSAB® Controls |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for changes to the output of the assay file interpretation screen and change of grayzone range. |
30-Day Notices (135 Day Supplement was not required)
| P790017/S093 12/11/07 |
Gruntzig Dilaca Coronary Artery Balloon Dilation Catheter | Medtronic Vascular Santa Rosa, CA 95403 |
Reduction in the number of in-process tensile test samples for the NC Stormer OTW and Sprinter OTW balloon dilatation catheter products at the bond bifurcate luer to inner shaft work-step. |
| P840001/S103 12/18/07 |
Spinal Cord Stimulation | Medtronic, Inc. Minneapolis, MN 55432 |
Removal of the thermal shock test as part of the battery manufacturing process. |
| P840001/S104 12/11/07 |
Itrel 3, Synergy, Restore Prime, and Prime Advanced Family of Implantable Pulse Generators or Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| P840064/S033 12/14/07 |
Viscoat®, Duovisc® and DisCoVisc® Ophthalmic Viscosurgical Devices | Alcon Research, Ltd. Fort Worth, TX 76134 |
Addition of a new analytical method for the determination of ethylene oxide residuals. |
| P860004/S095 12/11/07 |
SynchroMed II Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| P860057/S044 12/13/07 |
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Change in supplier for PET-yarn. |
| P870056/S027 12/13/07 |
Carpentier-Edwards Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Change in supplier for PET-yarn. |
| P870077/S025 12/13/07 |
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Change in supplier for PET-yarn. |
| P880086/S157 12/11/07 |
Affinity/Integrity/ Victory/Zephyr Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Alternate process for adhering the hybrid substrate to the hybrid support. |
| P880086/S158 12/14/07 |
Affinity/Integrity/ Victory/Zephyr Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Alternate manufacturing process for attachment of the header for the device. |
| P890003/S132 12/11/07 |
Prodigy/Thera I IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| P890047/S020 12/14/07 |
Provisc® Ophthalmic Viscosurgical | Alcon Research, Ltd. Fort Worth, TX 76134 |
Addition of a new analytical method for the determination of ethylene oxide residuals. |
| P890055/S024 12/18/07 |
FlexTip Plus Intraspinal Catheter Kit | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Change to: 1) the packaging location from Avid Medical to Codman & Shurtleff, Inc.; 2) the packaging component suppliers; and 3) the Touhy needles and ruler suppliers. |
| P910073/S068 12/19/07 |
RELIANCE Family of Leads | Guidant Corporation St. Paul, MN 55112 |
Automation of a manual trim process. |
| P910077/S081 12/5/07 |
VENTAK MINI, CONTAK RENEWAL 3 | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Changes to the seal plug bonding curing process. |
| P940031/S062 12/5/07 |
VIGOR DR/SR, DISCOVER/ MERIDIAN, PDP | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Changes to the seal plug bonding curing process. |
| P950022/S047 12/18/07 |
Riata Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Extended time between plasma treatment and application of medical adhesive. |
| P950022/S048 12/19/07 |
Riata Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Alternate oven settings during processing of shock coils. |
| P960009/S045 12/11/07 |
Kinetra and Soletra Family of Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| P960013/S036 12/18/07 |
Tendril Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Extended time between plasma treatment and application of medical adhesive. |
| P960040/S154 12/5/07 |
PRIZM/VITALITY | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Changes to the seal plug bonding curing process. |
| D970003/S094 12/5/07 |
INSIGNIA/NEXUS | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Changes to the seal plug bonding curing process. |
| P970003/S094 12/19/07 |
Vagus Nerve Stimulation (VNS) Therapy™ System | Cyberonics, Inc. Houston, TX 77058 |
Add additional details to the inspection criteria for delamination and constrained coil in Lead Models 302 and 303. |
| P970004/S045 12/18/07 |
InterStim® Therapy for Urinary Control | Medtronic, Inc. Minneapolis, MN 55432 |
Removal of the thermal shock test as part of the battery manufacturing process. |
| P970004/S046 12/11/07 |
InterStim Family of Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| P970012/S032 12/11/07 |
Kappa 400 DR IPG and Kappa 400 SR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| D970012/S044 12/21/07 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Change in the component material specification for the penile prosthesis. |
| P980016/S116 12/18/07 |
EnTrust and Virtuoso | Medtronic, Inc. Mounds View, MN 55112 |
Removal of the thermal shock process performed on battery feedthroughs at the supplier. |
| P980016/S117 12/11/07 |
Marquis DR/VR ICD, Maximo DR/VR ICD, Onyx ICD, Intrinsic ICD, EnTrust ICD, Virtuoso ICD |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| P980035/S082 12/18/07 |
EnRhythm | Medtronic, Inc. Mounds View, MN 55112 |
Removal of the thermal shock process performed on battery feedthroughs at the supplier. |
| P980035/S083 12/11/07 |
Kappa 600/700 650 IPG, Kappa 800/90 IPG, EnPulse IPG, Sigma IPG, Medtronic 350 Series IPG, AT500 IPG, EnRhythm IPG, Adapta/Versa/ Sensia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| P990009/S021 12/27/07 |
Floseal® Hemostatic Matrix | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Change in extrusion force stability limit. |
| P990081/S007 12/12/07 |
PATHWAY® anti-HER-2/neu (Clone 4B5) Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Change in the raw material used to manufacture cell line multiblocks to eliminate background staining of the control slides. |
| P000007/S013 12/13/07 |
Carpentier-Edwards Stentless Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Change in supplier for PET-yarn. |
| P000032/S023 12/20/07 |
Her Option® Office Cryoablation Therapy System | American Medical Systems Minnetonka, MN 55343 |
Change to the Cryoprobe handle for the device. |
| P000043/S020 12/17/07 |
TherMatrx Office Thermotherapy System | American Medical Systems, Inc. Minnetonka, MN 55343 |
Transfer of the label generation process for a catheter from the AMS Minnetonka facility to MRI Medical, in Tucson, Arizona. |
| P010012/S163 12/5/07 |
CONTAK RENEWAL/ VITALITY | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Changes to the seal plug bonding curing process. |
| P010015/S036 12/11/07 |
InSync CRT-P, InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| P010031/S086 12/18/07 |
Concerto | Medtronic, Inc. Mounds View, MN 55112 |
Removal of the thermal shock process performed on battery feedthroughs at the supplier. |
| P010031/S087 12/11/07 |
InSync CRT-D, InSync II Protect ICD, InSync Sentry ICD, InSync Maximo ICD, InSync Marquis ICD, Concerto ICD | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a paperless chart recorder to the sterilization operations at the Juncos, Puerto Rico manufacturing facility. |
| P010041/S014 12/13/07 |
Carpentier-Edwards Supraanular (S.A.V.) Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Change in supplier for PET-yarn. |
| P020004/S032 12/6/07 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore &Associates, Inc. Flagstaff, AZ 86001 |
Adoption of an electronic verification system (EVS) to be used in the packaging of the device. |
| P020026/S045 12/13/07 |
CYPHER® Sirolimus-eluting Coronary Stent | Cordis Corporation Miami Lakes, FL 33014 |
Modification to the laser cutting process. |
| P020026/S047 12/13/07 |
CYPHER® Sirolimus-eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Change in the quality control test used to determine media suitability for sustaining microbial growth for the Device. |
| P030005/S048 12/5/07 |
CONTAK RENEWAL TR | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Changes to the seal plug bonding curing process. |
| P030025/S050 12/27/07 |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 5511 |
Use of an intra-campus manufacturing site for the polymer excipient used in the device. |
| P030035/S038 12/11/07 |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Alternate process for adhering the hybrid substrate to the hybrid support. |
| P030039/S008 12/14/07 |
Coseal® Surgical Sealant | Baxter Healthcare Corp. McGaw Park, IL 60085 |
Change in supplier and a change to the syringe filling process. |
| P040027/S008 12/6/07 |
Gore Viatorr® TIPS Endoprosthesis | W.L. Gore &Associates, Inc. Flagstaff, AZ 86001 |
Adoption of an electronic verification system (EVS) to be used in the packaging of the device. |
| P040037/S006 12/6/07 |
Gore Viabahm® Endoprosthesis | W.L. Gore &Associates, Inc. Flagstaff, AZ 86001 |
Adoption of an electronic verification system (EVS) to be used in the packaging of the device. |
| P040040/S001 12/5/07 |
AMPLATZER® Muscular Ventricular Septal Defect Occluder | AGA Medical Corporation Plymouth, MN 55442 |
Change to an inspection procedure. |
| P040043/S020 12/6/07 |
Gore TAG® Thoracic Endoprosthesis | W.L. Gore &Associates, Inc. Flagstaff, AZ 86001 |
Adoption of an electronic verification system (EVS) to be used in the packaging of the device. |
| P050006/S005 12/6/07 |
Gore Helex Septal Occluder | W.L. Gore &Associates, Inc. Flagstaff, AZ 86001 |
Adoption of an electronic verification system (EVS) to be used in the packaging of the device. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 63
Summary of PMA Originals Under Review
Total Under Review: 72
Total Active: 25
Total On Hold: 47
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 409
Total Active: 227
Total On Hold: 182
Number Greater Than 180 Days: 13
Summary of All PMA Submissions Received
Originals: 3
Supplements: 99
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 63
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 126.4
FDA Time: 104.5 Days MFR Time: 21.9 Days
Updated January 24, 2008
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