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.
PMA Original Approvals
| P050026 4/4/06 |
Quantel Activis Laser and ZSL30 ACT™, ZSL120 ACT™, and HSBMBQ ACT™ Slit Lamp Adapters | QLT USA, Inc. Fort Collins, CO 80525 | Approval for the Quantel Activis Laser and ZSL30 ACT™, ZSL120 ACT™, and HSBMBQ ACT™ Slit Lamp Adapters. The device is indicated for the photoactivation of the light activated drug VISUDYNE (verteporfin for injection) in photodynamic therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia, or presumed ocular hystoplasmosis. |
PMA Supplemental Approvals
| P790007/S017 4/20/06 135-Day |
HANCOCK® Modified Orifice (MO) Valved Conduit | Medtronic Heart Valves Santa Ana, CA 92705 | Approval for the implementation of smaller capacity equipment and elimination of the shrink temperature testing used for the tissue fixation manufacturing process. |
| P820018/S076 4/28/06 Real-Time |
Aurora/Quadra, Reflex, Simplex, and Meta Pacemakers | St. Jude Medical CRMD Sunnyvale, CA 94086 | Approval for the Model 3307 v.6.1m programmer software. |
| P830045/S097 4/5/06 Real-Time |
Affinity/Integrity/ ADx, Photon/Atlas+/Epic, Microny/Regency, Frontier, Identity/Identity ADx, Paragon, Victory, Epic II and Frontier II Family of Devices | St. Jude Medical CRM Sylmar, CA 91342 | Approval for the Model 3330 Version 3.0 Software for use on the Model 3650 Merlin Patient Care System which adds the support for the use of Merlin with the Victory, Epic II and Frontier II pulse generator families. |
| P830045/S098 4/28/06 Real-Time |
Paragon, Phoenix, Multilog, and Sensorithm Pacemakers | St. Jude Medical CRMD Sunnyvale, CA 94086 | Approval for the Model 3307 v.6.1m programmer software. |
| P840039/S055 4/24/06 Real-Time |
Ultraviolet (UV) Absorbing and Non-UV Absorbing Polymethylmetha-crylate (PMMA) Posterior Chamber Intraocular Lenses (IOLs) | Bausch & Lomb San Dimas, CA 91773 | Approval for a change in the lens carrier to a rotary cap carrier. |
| P880006/S040 4/5/06 Real-Time |
Affinity/Integrity/ ADx, Photon/Atlas+/Epic, Microny/Regency, Frontier, Identity/Identity ADx, Paragon, Victory, Epic II and Frontier II Family of Devices | St. Jude Medical CRM Sylmar, CA 91342 | Approval for the Model 3330 Version 3.0 Software for use on the Model 3650 Merlin Patient Care System which adds the support for the use of Merlin with the Victory, Epic II and Frontier II pulse generator families. |
| P880006/S041 4/28/06 Real-Time |
Regency, Sensolog III, and Dialog II Pacemakers | St. Jude Medical CRMD Sunnyvale, CA 94086 | Approval for the Model 3307 v.6.1m programmer software. |
| P880086/S117 4/5/06 Real-Time |
Affinity/Integrity/ ADx, Photon/Atlas+/Epic, Microny/Regency, Frontier, Identity/Identity ADx, Paragon, Victory, Epic II and Frontier II Family of Devices | St. Jude Medical CRM Sylmar, CA 91342 | Approval for the Model 3330 Version 3.0 Software for use on the Model 3650 Merlin Patient Care System which adds the support for the use of Merlin with the Victory, Epic II and Frontier II pulse generator families. |
| P880086/S118 4/28/06 Real-Time |
Solus, Addvent, Solus II, Synchrony, Phoenix III, Trilogy, Affinity, Integrity, Entity, Identity, Verity, and Victory Pacemakers | St. Jude Medical CRMD Sunnyvale, CA 94086 | Approval for the Model 3307 v.6.1m programmer software. |
| P890003/S101 4/21/06 Real-Time |
Model 2090 Programmer | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the SessionSync™ feature as part of an enhancement to Model 9986 Desktop / Baseline Operating System Software (BOSS) versions 1.3.8/1.5 for the 2090 CareLink Programmer. SessionSync allows data transfer between the Model 2090 CareLink Programmer and the customer’s Paceart System (a data management system). |
| P890017/S014 4/21/06 Real-Time |
Cordis PALMAZ® Balloon Expandable Stent for Iliac and Renal Arteries | Cordis Corporation Warren, NJ 07059 | Approval to change the bacterial endotoxin test method to the Kinetic Chromogenic LAL test method, per 2005 USP 28, NF23, Chapter <85>. |
| P890064/S018 4/28/06 Real-Time |
Digene Hybrid Capture® 2 High-Risk HPV DNA Test, and Digene Hybrid Capture® 2 HPV DNA Test | Digene Corporation Gaithersburg, MD 20878 | Approval for a change in the sample conversion protocol for specimens collected in PreservCyt solution. The maximum number of specimens that can be processed at one time was increased from 20 to 36 specimens. |
| P900061/S063 4/21/06 Real-Time |
GEM Family (Model 7227) | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the SessionSync feature as part of an enhancement to Model 9986 Desktop / Baseline Operating System Software (BOSS) versions 1.3.8/1.5 for the 2090 CareLink Programmer. SessionSync allows data transfer between the Model 2090 CareLink Programmer and the customer’s Paceart System (a data management system). |
| P900070/S032 4/28/06 Real-Time |
Meta and Tempo Pacemakers | St. Jude Medical CRMD Sunnyvale, CA 94086 | Approval for the Model 3307 v.6.1m programmer software. |
| P910023/S086 4/20/06 135-Day |
St. Jude Medical ICDs/CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for a change in the epoxy used during the manufacturing process. |
| P910023/S093 4/20/06 135-Day |
St. Jude Medical ICDs/CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for an alternate silicone diode die for hybrid assemblies. |
| P910023/S103 4/5/06 Real-Time |
Affinity/Integrity/ ADx, Photon/Atlas+/Epic, Microny/Regency, Frontier, Identity/Identity ADx, Paragon, Victory, Epic II and Frontier II Family of Devices | St. Jude Medical CRM Sylmar, CA 91342 | Approval for the Model 3330 Version 3.0 Software for use on the Model 3650 Merlin Patient Care System which adds the support for the use of Merlin with the Victory, Epic II and Frontier II pulse generator families. |
| P910023/S104 4/28/06 Real-Time |
Epic II, Epic II+, Epic II VR, Epic II DR, and Epic II+ DR Implantable Cardioverter Defibrilators (Models V-158, V-255, V-258) and Model 3307 v.6.1m Software | St. Jude Medical CRMD Sunnyvale, CA 94086 | Approval for the Model 3307 v.6.1m programmer software. |
| P910073/S062 4/28/06 Real-Time |
ENDOTAK RELIANCE Family of Leads | Guidant Corporation St. Paul, MN 55112 | Approval for a tolerance change to the electrode base diameter, an increase in the electrode base diameter, a tolerance change to the electrode shell bearing surfaces, and a modification to the “o-ring” seat in the electrode shell to all active-fixation ENDOTAK RELIANCE Leads. |
| P930021/S009 4/24/06 Special |
Emdogain® | Straumann USA Andover, MA 01810 | Approval for the addition of post-market experience information to the Warning section of the Emdogain® package insert. |
| P950024/S007 180-Day 4/4/06 |
Medtronic CapSureEpi® Pacing Lead Models 4965 & 4968 | Medtronic, Inc. Shoreview, MN 55126 | Approval for modifications to the post-approval study for the device. |
| P950032/S043 4/21/06 Real-Time |
Apligraf | Organogenesis, Inc. Canton, MA 02021 | Approval for a change in product expiration dating from 5 days at 20-37º C to 15 days at 20-23ºC. |
| P950037/S043 4/24/06 Real-Time |
Actros, Axios, Cyloc, Dromos, Ergos, Gemnos, Kairos, Kalos, Nanos, Neos, Philos, Philos II, Pikos, Protos, Trios, and BA03 DDDR | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the ICS 3000 with Implant Module. |
| P960016/S016 4/21/06 Real-Time |
Livewire TC™ Cardiac Ablation System | St. Jude Medical Atrial Fibrillation Division Minnetonka, MN 55345 | Approval for the addition of the IBI 1500T6 RF Generator Extension Cables. |
| P960040/S100 4/24/06 Real-Time |
Prizm AICD System Models 1850, 1853, and 1900 | Guidant Corporation CRM St. Paul, MN 55112 | Approval for the retroactive manufacture process modification by inserting a coating of medical adhesive around the feedthru wires of the Prizm AICD System Models 1850, 1853, and 1900. |
| P960040/S106 4/20/06 135-Day |
VITALITY Family of ICDs | Guidant Corporation CRM St. Paul, MN 55112 | Approval for a change in the manufacturing test software and manufacturing process sequences. |
| P960040/S114 4/12/06 Special |
Ventak and Contak CD Families of ICDs | Guidant Corp. St. Paul, MN 55112 | Approval for modifications to the labeling for the Ventak (P960040) and Contak CD (P010012) families of implantable defibrillators to include information regarding behavior of these devices attributable to the SVO (silver vanadium oxide) used to power them. Specifically, an update to the System Guide to include language to identify as normal an increased charged time in midlife due to the inherent characteristics of the SVO batteries used. |
| P960040/S115 4/5/06 Real-Time |
Vitality HE, Renewal 3 and Renewal 3RF Families of ICDs | Guidant Corp., CRM St. Paul, MN 55112 | Approval for updates to the specifications of the devices regarding confirmation of meeting hermetic and arc suppression under high voltage requirements related to the atmospheric gas within the device. |
| P960058/S047 4/11/06 180-Day |
HiResolution Bionic Ear system | Advanced Bionics Corp. Sylmar, CA 91342 | Approval for a revision to the Auria behind-the-ear sound processor, which will be marketed under the trade name Auria Harmony. The revision incorporates new circuitry, firmware, and components, including a new Digital Signal Processor chip, internal telecoil, built-in diagnostic Light Emitting Diode (LED), improved Audio Front End, and enhanced FRF transmitter. |
| P970012/S022 4/21/06 Real-Time |
Kappa 4000 Family | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the SessionSync™ feature as part of an enhancement to Model 9986 Desktop / Baseline Operating System Software (BOSS) versions 1.3.8/1.5 for the 2090 CareLink Programmer. SessionSync allows data transfer between the Model 2090 CareLink Programmer and the customer’s Paceart System (a data management system). |
| P970013/S007 4/5/06 Real-Time |
Affinity/Integrity/ ADx, Photon/Atlas+/Epic, Microny/Regency, Frontier, Identity/Identity ADx, Paragon, Victory, Epic II and Frontier II Family of Devices | St. Jude Medical CRM Sylmar, CA 91342 | Approval for the Model 3330 Version 3.0 Software for use on the Model 3650 Merlin Patient Care System which adds the support for the use of Merlin with the Victory, Epic II and Frontier II pulse generator families. |
| P970013/S008 4/28/06 Real-Time |
Microny Pacemakers | St. Jude Medical CRMD Sunnyvale, CA 94086 | Approval for the Model 3307 v.6.1m programmer software. |
| P970031/S014 4/20/06 135-Day |
FREESTYLE® Aortic Root Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 | Approval for the implementation of smaller capacity equipment and elimination of the shrink temperature testing used for the tissue fixation manufacturing process. |
| P980016/S071 4/21/06 Real-Time |
GEM DR 7271, GEM II DR 7273, GEM II VR 7229, GEM III VR 7231, GEM III DR 7275, Onyx 7290, Intrinsic 30 7287, Intrinsic, 7288, Marquis DR 7274, Marquis VR 7230, Maximo DR 7278, Maximo VR 7232 | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the SessionSync™ feature as part of an enhancement to Model 9986 Desktop / Baseline Operating System Software (BOSS) versions 1.3.8/1.5 for the 2090 CareLink Programmer. SessionSync allows data transfer between the Model 2090 CareLink Programmer and the customer’s Paceart System (a data management system). |
| P980022/S013 4/7/06 180-Day |
Paradigm Real Time System | Medtronic MiniMed Northridge, CA 91325 | Approval for modifications to the MMT 515/715 external insulin pump and to the Guardian RT sensor to enable the pump to accept data from the sensor, and to enable the sensor to communicate directly to the pump. The device will be manufactured at Medtronic MiniMed, Northridge, California. |
| P980023/S021 4/24/06 Real-Time |
Cardiac Airbag | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the ICS 3000 with Implant Module. |
| P980035/S055 4/21/06 Real-Time |
Kappa 600/650/700/800/900 family, Sigma family (SDR303, SDR203, SDR306, SD303, SD203, SVDD303, SSR303, SSR203, SSR306, SS303, SS203, SS103, SS106, SVVI103), Sigma 350 series (DR353, SR353, VDD353), AT500 (Model AT501), Enpulse family (E1DR01, E1DR03, E1DR06, E1DR21), EnPulse II family (E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33, E2D01, E2D03, E2VDD01, E2SR01, E2SR03, E2SR06) | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the SessionSync™ feature as part of an enhancement to Model 9986 Desktop / Baseline Operating System Software (BOSS) versions 1.3.8/1.5 for the 2090 CareLink Programmer. SessionSync allows data transfer between the Model 2090 CareLink Programmer and the customer’s Paceart System (a data management system). |
| P980043/S007 4/20/06 135-Day |
HANCOCK® II Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 | Approval for the implementation of smaller capacity equipment and elimination of the shrink temperature testing used for the tissue fixation manufacturing process. |
| P980049/S020 4/28/06 180-Day |
Ovatio DR Model 6550 and Ovatio VR Model 6250 Implantable Cardioverter Defibrillators (ICDs), Elaview 1.32 UG2 Programming Software and CPR3 Programming Head with HSO 2.76 Software | ELA Medical, Inc. Plymouth, MN 55441 | Approval for an implantable cardioverter defibrillator (ICD) that combines features of the Alto 2 DR 624, Alto 2 VR 625 ICDs, and Symphony 2550 pacemaker, including reduced size, modified shock circuitry and other changes. The device will be marketed under the trade name Ovatio DR Model 6550 and Ovatio VR Model 6250 ICDs, Elaview 1.32 UG2 Programming Software and CPR3 Programming Head with HSO 2.76 Software and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: 1) Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, 2) Recurrent, poorly tolerated sustained ventricular tachycardia (VT). Note: The clinical outcome for hemodynamically stable VT patients is not fully known. Safety and Effectiveness studies have not been conducted. |
| P980050/S022 4/21/06 Real-Time |
GEM III AT 7276 | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the SessionSync™ feature as part of an enhancement to Model 9986 Desktop / Baseline Operating System Software (BOSS) versions 1.3.8/1.5 for the 2090 CareLink Programmer. SessionSync allows data transfer between the Model 2090 CareLink Programmer and the customer’s Paceart System (a data management system). |
| P990038/S011 4/19/06 Special |
ETI-MAK-2 PLUS | DiaSorin, Inc. Stillwater, MN 55082 | Approval for manufacturing changes in the way the positive control is made. |
| P990056/S002 4/12/06 Special |
Elecsys Total PSA Immunoassay | Roche Diagnostics Corporation Indianapolis, IN 46250 | Approval for implementation of an additional step into the standardization instructions for the Elecsys Total PSA Immunoassay. |
| P990064/S012 4/20/06 135-Day |
MOSAIC® Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 | Approval for the implementation of smaller capacity equipment and elimination of the shrink temperature testing used for the tissue fixation manufacturing process. |
| P990066/S021 4/11/06 180-Day |
Senographe DS Full Field Digital Mammography System | GE Healthcare Waukesha, WI 53188 | Approval for Senographe Essential Full Field Digital Mammography System with increased detector area to accommodate a larger range of breast sizes for the purpose of screening and diagnosis. |
| P990071/S008 4/19/06 Real-Time |
Stockert 70 RF Generator for Cardiac Ablation | Biosense Webster, Inc. Diamond Bar, CA 91765 | Approval for the Stockert 70 RF Generator Interface with the CoolFlow Irrigation Pump via a connection cable. |
| P000008/S009 4/24/06 180-Day |
LAP-BAND® Adjustable Gastric Banding (LAGB) System | Inamed Corporation Santa Barbara, CA 93111 | Approval for an extension to the LAP-BAND® Adjustable Gastric Banding (LAGB) product line to include the large and small LAP-BAND Advanced Platform (AP) design. |
| P000009/S017 4/24/06 Real-Time |
Belos, Lexos, Lumos, and Xelos | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the ICS 3000 with Implant Module. |
| P010003/S006 4/13/06 180-Day |
BioGlue Surgical Adhesive | Cryolife, Inc. Kennesaw, GA 30144 | Approval for two manufacturing sites: 1) Centurion Sterilization Services, part of Tri-State Hospital Supply, Salisbury, North Carolina for the sterilization of BioGlue Extender Tips; and 2) Command Medical Products, Ormond Beach, Florida as a component assembler. |
| P010012/S085 4/6/06 Real-Time |
CONTAK RENEWAL Programmer Software (SW) Model 2845 v4.33 | Guidant Corp. St. Paul, MN 55112 | Approval for the CONTAK RENEWAL Programmer Software (SW) Model 2845 v4.33 and applicable firmware (FW). |
| P010012/S098 4/20/06 135-Day |
CONTAK RENEWAL FAMILY of CRT-Ds | Guidant Corporation CRM St. Paul, MN 55112 | Approval for a change in the manufacturing test software and manufacturing process sequences. |
| P010012/S116 4/12/06 Special |
Ventak and Contak CD Families of ICDs | Guidant Corp. St. Paul, MN 55112 | Approval for modifications to the labeling for the Ventak (P960040) and Contak CD (P010012) families of implantable defibrillators to include information regarding behavior of these devices attributable to the SVO (silver vanadium oxide) used to power them. Specifically, an update to the System Guide to include language to identify as normal an increased charged time in midlife due to the inherent characteristics of the SVO batteries used. |
| P010012/S117 4/5/06 Real-Time |
Vitality HE, Renewal 3 and Renewal 3RF Families of ICDs | Guidant Corp., CRM St. Paul, MN 55112 | Approval for updates to the specifications of the devices regarding confirmation of meeting hermetic and arc suppression under high voltage requirements related to the atmospheric gas within the device. |
| P010015/S022 4/21/06 Real-Time |
InSync III 8042 | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the SessionSync™ feature as part of an enhancement to Model 9986 Desktop / Baseline Operating System Software (BOSS) versions 1.3.8/1.5 for the 2090 CareLink Programmer. SessionSync allows data transfer between the Model 2090 CareLink Programmer and the customer’s Paceart System (a data management system). |
| P010018/S009 4/6/06 180-Day |
ViewPoint® CK® System | Refractec, Inc. Irvine, CA 92618 | Approval for updating the labeling with the 24 month clinical study results for CK® treatment to improve near vision in the emmetropic and hyperopic presbyopes. |
| P010031/S038 4/21/06 Real-Time |
InSync ICD 7272, InSync Marquis 7277, InSync II/III Marquis 7289/7279, InSync Sentry 7297/7299, InSync Maximo 7303/7304 | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the SessionSync™ feature as part of an enhancement to Model 9986 Desktop / Baseline Operating System Software (BOSS) versions 1.3.8/1.5 for the 2090 CareLink Programmer. SessionSync allows data transfer between the Model 2090 CareLink Programmer and the customer’s Paceart System (a data management system). |
| P020002/S002 4/28/06 Real-Time |
ThinPrep Imaging System | Cytyc Corporation Marlborough, MA 01752 | Approval for software and labeling modifications of the ThinPrep Imaging System for remote reviewing capability & labeling change for the ThinPrep Imaging System to incorporate a new limitation for specimen reprocessing. |
| P020045/S014 4/6/06 Real-Time |
CCT.2 CryoAblation Console System | CryoCath Technologies, Inc. Kirkland, Quebec, Canada H9H 5H3 | Approval for the addition of the footswitch, additional EP connectivity, additional efficiency in verification and validation reporting, and the other minor changes listed on page 2 of the submission. |
| P030008/S004 4/19/06 Panel |
WaveLight ALLEGRETTO WAVE™ Excimer Laser System | SurgiVision® Refractive Consultants, Inc. North Reading, MA 01864 | Approval for the WaveLight ALLEGRETTO WAVE Excimer Laser System. The device used optical zones of 6.0-7.0 mm with an ablation/treatment zone up to 9.0 mm, and is indicated for laser assisted in situ keratomileusis (LASIK) for: 1) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 diopters (D) at the spectacle plane; 2) patients who are 21 years of age or older; and 3) patients with documentation of a stable manifest refraction defined as <= 0.50 D preoperative spherical equivalent shift over one year prior to surgery. |
| P030009/S002 4/21/06 180-Day |
Micro-Driver Over-The-Wire Coronary Stent System and Micro-Driver MX2 Coronary Stent System | Medtronic Vascular Santa Rose, CA 95403 | Approval for the Micro-Driver Over-The-Wire Coronary Stent System and the Micro-Driver MX2 Coronary Stent System. The systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions with reference vessel diameters of 2.25-2.75 mm and ≤21 mm in length. Outcome beyond 270 days for this permanent implant is unknown at present. |
| P030035/S011 4/5/06 Real-Time |
Affinity/Integrity/ ADx, Photon/Atlas+/Epic, Microny/Regency, Frontier, Identity/Identity ADx, Paragon, Victory, Epic II and Frontier II Family of Devices | St. Jude Medical CRM Sylmar, CA 91342 | Approval for the Model 3330 Version 3.0 Software for use on the Model 3650 Merlin Patient Care System which adds the support for the use of Merlin with the Victory, Epic II and Frontier II pulse generator families. |
| P030035/S012 4/28/06 Real-Time |
Frontier and Frontier II Biventricular Pacing Systems | St. Jude Medical CRMD Sunnyvale, CA 94086 | Approval for the Model 3307 v.6.1m programmer software. |
| P030054/S016 4/20/06 135-Day |
St. Jude Medical ICDs/CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for a change in the epoxy used during the manufacturing process. |
| P030054/S024 4/5/06 Real-Time |
Affinity/Integrity/ ADx, Photon/Atlas+/Epic, Microny/Regency, Frontier, Identity/Identity ADx, Paragon, Victory, Epic II and Frontier II Family of Devices | St. Jude Medical CRM Sylmar, CA 91342 | Approval for the Model 3330 Version 3.0 Software for use on the Model 3650 Merlin Patient Care System which adds the support for the use of Merlin with the Victory, Epic II and Frontier II pulse generator families. |
| P030054/S025 4/28/06 Real-Time |
Epic HF & Epic II HF Cardiac Resynchronization Therapy Defibrillator (Model V-355) and Model 3307 v.6.1m Software | St. Jude Medical CRMD Sunnyvale, CA 94086 | Approval for the Model 3307 v.6.1m programmer software. |
| P040002/S004 4/14/06 Real-Time |
Endologix PowerLink® System | Endologix, Inc. Irvine, CA 92618 | Approval for two new bifurcated body sizes listed as models 25-16-120BL and 28-16-120BL. |
| P040005/S001 4/21/06 180-Day |
HER2 FISH pharmDX™ Kit | DakoDenmark A/S Glostrup, Denmark DK-2600 | Approval for a manufacturing site located at Dako Denmarks A/S, Glostrup, Denmark. |
30-Day Notices (135 Day Supplement was not required)
| P910077/S058 4/26/06 |
MINI Implantable Pacemakers | Guidant Corporation St. Paul, MN 55112 | Alternative suppliers for the connector blocks and set screws. |
| P940031/S052 4/26/06 |
MERIDIAN/ DISCOVERY Implantable Pacemakers | Guidant Corporation St. Paul, MN 55112 | Alternative suppliers for the connector blocks and set screws. |
| P960040/S116 4/21/06 |
INSIGNIA/NEXUS, PRIZM/VITALITY & CONTAK RENEWAL Families | Guidant Corporation St. Paul, MN 55112 | Implementation of additional products on existing Inner Lead Bonding (ILB) machines. |
| P960040/S117 4/26/06 |
VITALITY and VITALITY 2 Families | Guidant Corporation St. Paul, MN 55112 | Changes to the test software. |
| P960040/S119 4/26/06 |
VENTAK Implantable Cardioverter Defibrillators | Guidant Corporation St. Paul, MN 55112 | Alternative suppliers for the connector blocks and set screws. |
| P960040/S120 4/26/06 |
CONTAK RENEWAL Cardiac Resynchronization Therapy Defibrillator (CRT-D) | Guidant Corporation St. Paul, MN 55112 | Updates to the test software and test hardware. |
| D970003/S068 4/21/06 |
INSIGNIA/NEXUS, PRIZM/VITALITY & CONTAK RENEWAL Families | Guidant Corporation St. Paul, MN 55112 | Implementation of additional products on existing Inner Lead Bonding (ILB) machines. |
| D970003/S069 4/26/06 |
PULSAR MAX Implantable Pacemakers | Guidant Corporation St. Paul, MN 55112 | Alternative suppliers for the connector blocks and set screws. |
| P980035/S056 4/21/06 |
Sigma Pacemakers | Medtronic, Inc. Shoreview, MN 55126 | Reduction of burn-in time for Medtronic Sigma devices. |
| P000037/S011 4/7/06 |
On-X® Prosthetic Heart Valve | Medical Carbon Research Institute, LLC Austin, TX 78754 | Lowering the minimum total gas flow for leaflet coatings. |
| P000044/S011 4/3/06 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and the VITROS Immunodiagnostic Products HBsAg Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 | Additional raw material and release tests used in the manufacture of the VITROS HBsAg Confirmatory Kit. |
| P010012/S119 4/14/06 |
CONTAK RENEWAL RF | Guidant Corporation St. Paul, MN 55112 | Change to the Test Requirement Specifications (TRS) that specifies radio frequency (RF) testing for CONTAK RENEWAL RF Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, as well as corresponding testing software updates per routine procedures. |
| P010012/S120 4/21/06 |
INSIGNIA/NEXUS, PRIZM/VITALITY & CONTAK RENEWAL Families | Guidant Corporation St. Paul, MN 55112 | Implementation of additional products on existing Inner Lead Bonding (ILB) machines. |
| P010012/S122 4/26/06 |
CONTAK CD Cardiac Resynchronization Therapy Defibrillators | Guidant Corporation St. Paul, MN 55112 | Alternative suppliers for the connector blocks and set screws. |
| P010012/S123 4/26/06 |
VITALITY HE Intra-cardiac Defibrillator (ICD) | Guidant Corporation St. Paul, MN 55112 | Updates to the test software and test hardware. |
| P020045/S017 4/12/06 |
Freezor® Cardiac CryoAblation Catheters and Freezor® Xtra Surgical CryoAblation Catheters & CCT.2 CryoConsole System | Applied physics Brookline, MA 02445 | Change to the internal quality control and inspection process. |
| P030005/S033 4/26/06 |
RENEWAL TR Cardiac Resynchronization Therapy Defibrillators | Guidant Corporation St. Paul, MN 55112 | Alternative suppliers for the connector blocks and set screws. |
| P040028/S001 4/11/06 |
Luma Cervical Imaging System | MediSpectra, Inc. Lexington, MA 02421 | Modifications to the incoming camera inspection test, test software used to assemble the LUMA system and the final test software used during burn-in. |
| P030005/S033 4/26/06 |
RENEWAL TR Cardiac Resynchronization Therapy Defibrillators | Guidant Corporation St. Paul, MN 55112 | Alternative suppliers for the connector blocks and set screws. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 66
Summary of PMA Originals Under Review
Total Under Review: 101
Total Active: 47
Total On Hold: 54
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 407
Total Active: 235
Total On Hold: 172
Number Greater Than 180 Days: 13
Summary of All PMA Submissions Received
Originals: 1
Supplements: 93
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 66
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 91.6
FDA Time: 77.1 Days MFR Time: 14.5 Days
Updated May 15, 2006
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