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.
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P060039 6/13/08 |
Attain StarFix™ Model 4195 Lead | Medtronic, Inc. Shoreview, MN 55126 |
Approval for the Attain StarFix™ Model 4195 Lead. The Attain StarFix™ Model 4195 steroid eluting, transvenous lead with deployable lobe fixation is intended for chronic pacing and sensing of the left ventricle via the cardiac vein, when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator. |
| P070007 6/5/08 |
Talent™ Thoracic Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the Talent™ Thoracic Stent Graft System. The device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/ penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: 1) iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; 2) non-aneurysmal aortic diameter in the range of 18-42mm; and 3) non-aneurysmal aortic proximal and distal neck lengths >=20mm. |
| P070013 6/27/08 |
EVOLENCE® Collagen Filler | Johnson & Johnson Consumer and Personal Products Worldwide Skillman, NJ 08588 |
Approval for the EVOLENCE® Collagen Filler, which is indicated for the correction of moderate to deep facial wrinkles and folds such as nasolabial folds. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810002/S062 6/24/08 135-Day |
St. Jude Medical® Mechanical Heart Valve | St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for modifying the settings of the process input parameters for the Pyrolytic carbon coating process. |
| P820076/S024 6/2/08 Real-Time |
Stratos LV & Stratos LV-T CRT-P’s | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for Programmer software version 801.U. |
| P830061/S042 6/11/08 135-Day |
CapSure Sense and Vitatron Family of Devices | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a facility transfer for a component manufacturer. |
| P880006/S058 6/27/08 Real-Time |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the Model 3330 Version 6.8.1 Software for use on Model 3650 Merlin Patient Care System. |
| P880086/S164 6/27/08 Real-Time |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the Model 3330 Version 6.8.1 Software for use on Model 3650 Merlin Patient Care System. |
| P880090/S024 6/9/08 Real-Time |
Anterior Chamber Polymethylmetha-crylate (PMMA) Intraocular Lenses (IOLs) | Bausch & Lomb Rochester, NY 14609 |
Approval to change the lens carrier to the rotary cap carrier, pn/ 14937-62, for the anterior chamber IOLs. |
| P900056/S092 6/10/08 Special |
Rotablator™ Rotational Angioplasty System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for changes to the Directions for Use (DRU) for the RotaLink™ Exchangeable Catheter. |
| P910023/S175 6/24/08 Real-Time |
Atlas DR, Convert, Current, Epic DR ICD fAmilies | St. Jude Medical Cardiac Rhythm Disease Management Sunnyvale, CA 94086 |
Approval for minor modifications and standardization of the ground connection, output flex, heat shield, and battery support for Atla, Atlas II, Convert, Current, Epic, Epic II, and Promote CRT-D and ICD families. |
| P910023/S178 6/13/08 Real-Time |
Cadence family of ICD’s | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the Model EX2000 V. 2.0 version software for use on the St. Jude Medical Merlin@home DM EX1200 device. |
| P910023/S180 6/27/08 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the Model 3330 Version 6.8.1 Software for use on Model 3650 Merlin Patient Care System. |
| P910077/S087 6/26/08 Real-Time |
Latitude™ Communicator Software & System Software | Guidant Corporation St. Paul, MN 55112 |
Approval for change to the Latitude Communicator Software Model 6482), versions 1.8 and 2.2, and the Latitude Inductive Communicator Software (Model 6481) version 1.4. |
| P920047/S037 6/13/08 180-Day |
Blazer II Cardiac Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Approval for a manufacturing site located at Boston Scientific Corporation, San Jose, California. |
| P930039/S027 6/11/08 135-Day |
CapSureFix Novus and Vitatron Family of Devices | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a facility transfer for a component manufacturer. |
| P940015/S011 6/9/08 180-Day |
Synvisc | Genzyme Corporation Cambridge, MA 02142 |
Approval for the replacement of the dilution statement from the “Precaution” section and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. |
| P940035/S005 6/3/08 180-Day |
NMP22® ELISA Test Kit | Matritech, Inc. Newton, MA 02460 |
Approval for a manufacturing site located at Binax, Inc., Scarborough, Maine. |
| P950018/S010 6/4/08 180-Day |
Perfluoron™ | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for an alternate sterilization site located at Alcon Research, Ltd., Fort Worth, Texas. |
| P950034/S031 6/20/08 Special |
Seprafilm® Adhesion Barrier | Genzyme Biosurgery Cambridge, MA 02142 |
Approval for the addition of visual representations of the Directions for Use section of the current approved Package Insert. |
| P950037/S060 6/2/08 Real-Time |
Dromos DR/DR-A and Dromos SR/SR-B | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for Programmer software version 801.U. |
| P950037/S061 6/9/08 Real-Time |
Dromos DR/DR-A and Dromos SR/SR-B | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for minor mechanical changes to the ICS 3000 Programmer including removal of magnets from the PGH Wand and replacement of an existing connector as well as associated labeling updates. |
| P960043/S063 6/12/08 Real-Time |
Perclose® ProGlide™ 6 French Suture-Mediated Closure (SMC) Systems | Abbott Vascular Devices Redwood City, CA 94063 |
Approval for changing from the Surgipro II suture to the modified Surgipro II suture. |
| D970003/S099 6/16/08 Real-Time |
INSIGNIA and ALTRUA Pacemakers | Guidant St. Paul, MN 55112 |
Approval for changes to the jumper chip used on hybrid circuit components. |
| P970013/S025 6/27/08 Real-Time |
Microny Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the Model 3330 Version 6.8.1 Software for use on Model 3650 Merlin Patient Care System. |
| P980003/S018 6/13/08 180-Day |
Chilli II Cooled Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for a manufacturing site located at Boston Scientific Corporation, San Jose, California. |
| P980023/S032 6/2/08 Real-Time |
Phylax Implantable Cardioverter Defibrillator | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for Programmer software version 801.U. |
| P980023/S033 6/9/08 Real-Time |
Phylax Implantable Cardioverter Defibrillator | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for minor mechanical changes to the ICS 3000 Programmer including removal of magnets from the PGH Wand and replacement of an existing connector as well as associated labeling updates. |
| P980037/S024 6/17/08 180-Day |
AngioJet Rheolytic Thrombectomy System | Possis Medical, Inc. Coon Rapids, MN 55433 |
Approval for an alternative hydrophilic coating material and supplier (DSM Biomedical, Gleen, Netherlands) used on the distal shaft of the Spiroflex family of catheters (Spiroflex and Sprioflex VG) and approval to perform the manufacturing coating process of the new DSM hydrophilic coating at the Possis facility, Minneapolis, Minnesota. |
| P000006/S007 6/13/08 180-Day |
Coloplast Titan® Inflatable Penile Prosthesis with One-Touch Release (OTR) Pump Body | Coloplast Corporation Minneapolis, MN 55411 |
Approval for: 1) revision of the current Titan® prosthesis to include a new one-touch release pump body; 2) addition of NuSil Technology MED-4755 silicone as an optional alternative to the currently used NuSil Technology MED-4515 and MED-4750 silicones; 3) addition of a 1.5cm rear tip extender in the Titan® assembly kits; 4) addition of a specification imposing a lower limit of 2.5 lb for tactile force for deflation using the OTR pump; and 5) labeling revisions relating to the above device changes. The device, as modified, will be marketed under the trade name Titan® OTR Inflatable Penile Prosthesis and is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis. |
| P000009/S027 6/2/08 Real-Time |
Phylax AV ICD System | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for Programmer software version 801.U. |
| P000009/S028 6/9/08 Real-Time |
Phylax AV ICD System | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for minor mechanical changes to the ICS 3000 Programmer including removal of magnets from the PGH Wand and replacement of an existing connector as well as associated labeling updates. |
| P000025/S033 6/20/08 Real-Time |
SONATA TI 100 Cochlear Implant | MED-EL Elektro-Medizinische Geräte GmbH Fürstenweg, Austria |
Approval for the use of an alternative Hybrid component in the manufacture of the SONATA TI 100 cochlear implant called the “SONATA Hybrid 2”. The device, as modified, will be marketed under the trade name SONATA TI 100 Cochlear Implant and is indicated for the following patient populations: Adults eighteen (18) years of age or older who have bilateral, sensorineural hearing impairment and obtain limited benefit from appropriately fitted binaural hearing aids. These individuals typically demonstrate bilateral severe to profound sensorineural hearing loss determined by a pure tone average of 70 dB or greater at 500 Hz, 1000 Hz, and 2000 Hz. Limited benefit from amplification is defined by test scores of 40% correct or less in best-aided listening condition on CD recorded tests of open-set sentence recognition (Hearing In Noise Test [HINT] sentences). Children aged twelve (12) months to seventeen (17) years eleven (11) months must demonstrate a profound, bilateral sensorineural hearing loss with thresholds of 90 dB or greater at 1000 Hz. In younger children, little or no benefit is defined by lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three (3) to six (6) month period. In older children, lack of aid benefit is defined as < 20% correct on the Multi-syllabic Lexical Neighbourhood Test (MLNT) or Lexical Neighbourhood Test (LNT), depending upon the child's cognitive ability and linguistic skills. A three (3) to six (6) month hearing aid trial is required for children without previous experience with hearing aids. Radiological evidence of cochlear ossification may justify a shorter trial with amplification. |
| P000029/S045 6/18/08 Special |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Approval for introducing a QC (Quality Control) sample and a MS Excel calculation template to the test method for determining protein content in HA (hyaluronic acid) raw material. |
| P000029/S046 6/25/08 Special |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Approval for changes in the Precautions and Directions for Use sections of the Package Insert. |
| P010019/S009 6/10/08 180-Day |
CIBA VISION® Extended Wear Soft Contact Lenses known as CIBA VISION® (Lotrafilcon B) Soft Contact Lenses and CIBA VISION® (Lotrafilcon A) Soft Contact Lenses |
CIBA VISION Corp. Duluth, CA 30097 |
Approval for a manufacturing site located at Johor, Malaysia for front end contact lens processing. |
| P020014/S015 6/10/08 Special |
Conceptus Essure® System for Permanent Birth Control | Conceptus, Inc. Mountain View, CA 94041 |
Approval for labeling changes regarding concomitant Essure and endometrial ablation procedures. |
| P020018/S025 6/19/08 135-Day |
Zenith® Endovascular Graft | Cook, Inc. Bloomington, IN 47402 |
Approval for a change from an Oxyfume blend ethylene oxide (EtO) sterilant to the use of 100% EtO sterilant in the current sterilization cycle for the zenith family of devices and the addition of a supplier of the sterilant. |
| P020018/S027 6/4/08 Special |
Zenith® Flex™ AAA Endovascular Graft | Cook, Inc. Bloomington, IN 47402 |
Approval for the addition of a quality control step verifying the orientation of the converter while it is being loaded into the delivery catheter. |
| P020025/S019 6/13/08 180-Day |
Blazer II XP Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Approval for a manufacturing site located at Boston Scientific Corporation, San Jose, California. |
| P030002/S014 6/19/08 180-Day |
crystalens™ Accommodating Posterior Chamber Intraocular Lens (AIOL), Models AT-45-HD100, HD500, and HD520 | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Approval to market the following models in 0.5 diopter increments: Models AT-45-HD100 (10 to 33 diopters), HD500 (17.0 to 33.0 diopters), and HD520 (10 to 16.5 diopters). Additionally, approval to recommend use of the STAAR MSI-PR/TR and MSI-PF/TF injectors with MTC-60c cartridge to deliver these lens models. |
| P030002/S015 6/13/08 180-Day |
crystalens™ Model AT-45 Accommodating Intraocular Lens | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Approval for an alternate manufacturing site located at Bausch & Lomb, Inc., Rancho Cucamonga, California. |
| P030017/S026 6/23/08 1355-Day |
Precision® Spinal Cord Stimulator System | Boston Scientific Neuromodulation Corporation Sylmar, CA 91342 |
Approval for a change in the IPG resistance welding process of the antenna wire. |
| P030035/S043 6/27/08 Real-Time |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the Model 3330 Version 6.8.1 Software for use on Model 3650 Merlin Patient Care System. |
| P030054/S088 6/24/08 Real-Time |
Atlas HF, Epic HF CRT-D Families, Promote ICD Families | St. Jude Medical Cardiac Rhythm Disease Management Sunnyvale, CA 94086 |
Approval for minor modifications and standardization of the ground connection, output flex, heat shield, and battery support for Atla, Atlas II, Convert, Current, Epic, Epic II, and Promote CRT-D and ICD families. |
| P030054/S092 6/13/08 Real-Time |
Cadence family of ICD’s | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the Model EX2000 V. 2.0 version software for use on the St. Jude Medical Merlin@home DM EX1200 device. |
| P030054/S094 6/27/08 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the Model 3330 Version 6.8.1 Software for use on Model 3650 Merlin Patient Care System. |
| P040002/S017 6/12/08 Real-Time |
Endologix PowerLink® System, Visiflex IS Delivery Catheters | Endologix, Inc. Irvine, CA 92618 |
Approval for the new Visiflex IS bifurcated and straight delivery catheters. |
| P040020/S010 6/20/08 180-Day |
AcrySof® IQ ReSTOR® Apodized Diffractive Posterior Chamber IOL, Model SN6AD3 | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for changing the trade name of the device from AcrySof® ReSTOR® Aspheric Apodized Diffractive Posterior Chamber Intraocular Lens (IOL) to AcrySof® IQ ReSTOR® Apodized Diffractive Posterior Chamber IOL. The device will be marketed under the trade name AcrySof® IQ ReSTOR® Apodized Diffractive Posterior Chamber IOL, Model SN6AD3, and is indicated for primary implantation in the capsular bag for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. |
| P040024/S015 6/13/08 135-Day |
Restylane® Injectable Gel | Medicis Aesthetics Scottsdale, AZ 85258 |
Approval for new processing vessels and for changes in the cleaning process for those vessels. |
| P040024/S016 6/13/08 135-Day |
Restylane® Injectable Gel | Medicis Aesthetics Scottsdale, AZ 85258 |
Approval for new processing vessels and for changes in the cleaning process for those vessels. |
| P040033/S007 6/20/08 135-Day |
Birmingham Hip Resurfacing (HBR) System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for automation of two manufacturing processes utilizing CNC machining. |
| P050023/S012 6/2/08 Real-Time |
Kronos LV-T CRT-D |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for Programmer software version 801.U. |
| P050023/S013 6/9/08 Real-Time |
Kronos LV-T CRT-D |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for minor mechanical changes to the ICS 3000 Programmer including removal of magnets from the PGH Wand and replacement of an existing connector as well as associated labeling updates. |
| P050038/S005 6/23/08 180-Day |
Arista™ AH & HemoStace™ MPH | Medafor, Inc. Minneapolis, MN 55430 |
Approval for the addition of a new trade name. The device, as modified, will be marketed under the trade name HemoStase™ MPH and is indicated for use in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of capillary, venous, and arterial bleeding by pressure, ligature and other conventional procedures are ineffective or impractical. |
| P060019/S004 6/13/08 Real-Time |
Therapy™ Cool Path™ Ablation Catheter and IBI-1500T9 RF Ablation Generator |
Irvine Biomedical, Inc. Irvine, CA 92614 |
Approval for extension of ablation time from 60 to 120 seconds for the Cool Path catheters, and modifications to the labeling and user interface to accomplish this. |
| P070007/S001 6/27/08 180-Day |
Talent Thoracic Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for use of the new Xcelerant Delivery System with the Talent Thoracic Stent Graft. |
| P070008/S002 6/2/08 Real-Time |
Stratos LV CRT-P and Stratos LV-T CRT-P’s | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for Programmer software version 801.U. |
| P070008/S003 6/24/08 Real-Time |
Stratos LV and Stratos LV-T CRT-P’s | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for a diode change in the Stratos LV and LV-T CRT-Ps. The device, as modified, will be marketed under the trade name Stratos LV CRT-P and Stratos LV-T CRT-P and is indicated for treatment of bradycardia in heart failure patients. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P790018/S048 6/26/08 |
Medtronic Hall™ Rotatable Aortic Valved Collagen Impregnated Conduit, Model R7700 | Medtronic, Inc. Medtronic Cardiac Surgery Minneapolis, MN 55432 |
Change in raw material supplier. |
| P840001/S113 6/10/08 |
Restore Family of Neurostimulator Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Add a new component vendor to supply two integrated circuits (ICs) for use on the hybrids in the Restore family of devices. |
| P860019/S226 6/19/08 |
Maverick (Over-the-Wire), Maverick2 (Monorail), Maverick XL, Quantum Maverick (Monorail and Over-the-Wire) | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Addition of a new computer assisted label inspection system. |
| P860057/S046 6/6/08 |
Carpentier-Edwards® Perimount® Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Additional supplier for bovine pericardial tissue used in the manufacture of the device. |
| P880006/S057 6/9/08 |
Regency | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to sterilize products for up to five cycles at the contract sterilization vendor. |
| P880086/S163 6/9/08 |
AddVent, Affinity, Identity, Verity, Integrity, Victory, Zephyr | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to sterilize products for up to five cycles at the contract sterilization vendor. |
| P910023/S176 6/9/08 |
Cadence | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to sterilize products for up to five cycles at the contract sterilization vendor. |
| P910023/S177 6/19/08 |
Cadence Family of Implantable Cardioverter Defibrillators (ICDs) | St. Jude Medical Cardiac Rhythm Disease Management Sunnyvale, CA 94086 |
Alternate suppliers for discrete components used in the assembly of ICD and CRT-D devices. |
| P920023/S025 6/27/08 |
AMS UroLume Endoprosthesis | American Medical Systems Minnetonka, MN 55343 |
Change in vendor for the plastic injection molded parts of the device and the addition of an in-process pull-out test to the current manufacturing procedure. |
| P950020/S029 6/6/08 |
Coronary Flextome Cutting Balloon | Boston Scientific Corporation San Diego, CA 92121 |
Change to the in-process balloon inflation pressure for models of the Flextome Cutting Balloon. |
| P950022/S053 6/9/08 |
Rata, Riata ST, Durata | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to sterilize products for up to five cycles at the contract sterilization vendor. |
| P960013/S040 6/9/08 |
Tendril, Tendril ST, OptiSense | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to sterilize products for up to five cycles at the contract sterilization vendor. |
| P960030/S022 6/9/08 |
Passive Plus, IsoFlex S, IsoFlex P, IsoFlex Optim |
St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to sterilize products for up to five cycles at the contract sterilization vendor. |
| P970004/S057 6/27/08 |
InterStim II® Model 3058 Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of a rework process involving the removal and replacement of a connector block. |
| P970013/S024 6/9/08 |
Microny | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to sterilize products for up to five cycles at the contract sterilization vendor. |
| P980016/S131 6/19/08 |
EnTrust, Virtuoso, Secura DR/VR, and Maximo II DR/VR Family of Implantable Cardioverter Defibrillators (ICDs) | Medtronic, Inc. Moundsview, MN 55112 |
Manufacturing process change for bond pad arrays. |
| P980022/S027 6/16/08 |
Guardian REAL-Time Monitor | Medtronic MiniMed Northridge, CA 91325 |
Minor change to the vibrator motor. |
| P980035/S093 6/11/08 |
Adapta/Versa/ Sensia Implantable pulse Generators | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to the manufacturing test software for the devices. |
| P980035/S094 6/19/08 |
Adapta, Versa, and Sensia Family of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Moundsview, MN 55112 |
Manufacturing process change for bond pad arrays. |
| P980035/S096 6/25/08 |
Adapta, Versa, and Sensia Implantable pulse Generator Programming Software | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Replacement of existing epoxy dispensers used in the manufacture of the Adapta, Versa, and Sensia Implantable Pulse Generators (IPGs). |
| P980040/S024 6/23/08 |
Technis One-Piece Soft Acrylic Intraocular Lens, Model ZCB00 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the tumbling process to improve process consistency and reduce manufacturing costs. |
| P990013/S020 6/4/08 |
STAAR Surgical Collamer® Ultraviolet-Absorbing Posterior Chamber Intraocular Lens | STAAR Surgical Company Monrovia, CA 91016 |
Change to implement a new HAAS Office Milling machine at the Monrovia, California manufacturing facility used for milling Collamer Intraocular lenses. |
| P000025/S034 6/13/08 |
MED-EL COMBI 40+ Cochlear Implant System | MED-EL Elektro-Medizinische Geräte GmbH Fürstenweg, Austria |
Movement of an existing process step to a later stage of the manufacturing process. |
| P000044/S018 6/12/08 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator and VITROS Immunodiagnostic Products HBsAg Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester, NY 1426 |
Addition of a news supplier for human defibrinated anti-HBs negative plasma and updating of the raw material documentation. |
| P010003/S012 6/24/08 |
BioGlue® Surgical Adhesive | CryoLife, Inc. Kennesaw, GA 30144 |
Addition of an automated pump for dispensing Bovine Serum Albumin and Gluteraldehyde in the manufacture of BioGlue® Surgical Adhesive. |
| P010031/S100 6/19/08 |
Concerto, Consulta CRT-D, and Maximo II CRT-D Family of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
Medtronic, Inc. Moundsview, MN 55112 |
Manufacturing process change for bond pad arrays. |
| P020004/S036 6/5/08 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Automating a manual sewing process. |
| P020009/S044 6/19/08 |
Express 2 (Monorail and Over-the-Wire) | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Addition of a new computer assisted label inspection system. |
| P030009/S024 6/6/08 |
Driver Rapid Exchange (RX) Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Removal of several visual and dimensional inspection steps in the manufacture of the device. |
| P030025/S056 6/19/08 |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary System (Monorail and Over-the-Wire) | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Addition of a new computer assisted label inspection system. |
| P030035/S042 6/9/08 |
Frontier, Frontier II, Aescula | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to sterilize products for up to five cycles at the contract sterilization vendor. |
| P030054/S089 6/9/08 |
Epic HF, QuickSite, QuickFlex | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to sterilize products for up to five cycles at the contract sterilization vendor. |
| P030054/S090 6/19/08 |
Epic HF Family of Cardiac Resynchronization Therapy Defibrillators | St. Jude Medical Cardiac Rhythm Disease Management | Alternate suppliers for discrete components used in the assembly of ICD and CRT-D devices. |
| P030054/S091 6/11/08 |
QuickSite and QuickFlex Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Use of a boot clamp manufacturing tool for QuickSite and QuickFlex leads. |
| P040014/S007 6/9/08 |
Therapy Cardiac Ablation Catheter | Irvine Biomedical, Inc. Irvine, CA 92614 |
Additional suppliers for the device. |
| P040016/S031 6/19/08 |
Liberté (Monorail and Over-the-Wire) | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Addition of a new computer assisted label inspection system. |
| P040042/S012 6/9/08 |
Therapy Dual 8, Therapy and Safire TX Ablation Catheters | Irvine Biomedical, Inc. Irvine, CA 92614 |
Additional suppliers for the device. |
| P050006/S007 6/11/08 |
GORE HELEX™ Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change from a manual to an automated process for the upper and lower temperature bonding set point and reject limits of the HELEX leaflet bonding process. |
| P050006/S008 6/19/08 |
GORE HELEX Septal Occluder | W.L. Gore & Associates Flagstaff, AZ 86001 |
Relocation of the delivery components manufacturing process from one facility to another within the Gore Medical facility. |
| P050020/S005 6/2/08 |
Freestyle Navigator® Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 |
Change for minor modifications to the device components. |
| P060001/S007 6/26/08 |
Protégé GPS and Protégé RX Carotid Stent Systems | Ev3, Inc. Plymouth, MN 55442 |
Move manufacturing of a component in-house and add an alternate tent compaction method. |
| P060033/S008 6/6/08 |
Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Use of a 50mm stent storage and transportation vial within the Endeavor Stent manufacturing process. |
| P060033/S009 6/26/08 |
Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Use of a conical base spray jar assembly within the Endeavor Stent manufacturing process. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 55
Summary of PMA Originals Under Review
Total Under Review: 72
Total Active: 32
Total On Hold: 40
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 496
Total Active: 335
Total On Hold: 161
Number Greater Than 180 Days: 12
Summary of All PMA Submissions Received
Originals: 1
Supplements: 167
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 5
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 104.7
FDA Time: 58.9 Days MFR Time: 45.8 Days
Updated July 29, 2008
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
