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
|
7/3/07 |
Cormet Hip Resurfacing System |
Corin USA Tampa , FL 33612 |
Approval for the Cormet Hip Resurfacing System. The Cormet Hip Resurfacing System is a single use device intended for hybrid fixation: cemented femoral head and cementless acetabular component. The device is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non-inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; 2) inflammatory arthritis such as rheumatoid arthritis. The Cormet Hip Resurfacing System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision. |
|
7/5/07 |
Novation™ Ceramic Articulation Hip System |
Exactech, Inc. Gainsville , FL 32653 |
Approval for the Novation™ Ceramic Articulation Hip System. This device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis. |
|
7/23/07 |
FLAIR™ Endovascular Stent Graft |
Bard Peripheral Vascular, Inc. Tempe , AZ 85280 |
Approval for the FLAIR™ Endovascular Stent Graft. The device is indicated for use in the treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts. |
|
7/16/07 |
GeneSearch Breast Lymph Node (BLN) Assay |
Veridex, LLC Warren , NJ 07059 |
Approval for the GeneSearch Breast Lymph Node (BLN) Assay. This device is indicated as a qualitative, in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra‑operative or post-operative decision to remove additional lymph nodes. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Veridex lymph node cutting scheme, is required. |
|
7/16/07 |
PRESTIGE® Cervical Disc System |
Medtronic Sofamor Danek Memphis , TN 38132 |
Approval for the PRESTIGE® Cervical Disc System. This device is indicated for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy . The PRESTIGE® device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e.g., pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (e.g., CT, MRI, x-rays, etc.): 1) herniated disc, and/or 2) osteophyte formation. |
PMA Supplemental Approvals
P870072/S036 7/27/07 Real-Time |
Thoratec Implantable Ventricular Assist Device (IVAD) System |
Thoratec Corporation Pleasanton , CA 94588 |
Approval for a change in the design of the Thoratec Implantable Ventricular Assist Device System’s pneumatic line. |
P880086/S150 7/12/07 Real-Time |
St. Jude Medical Identity and Identity ADx Family of Devices |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for use of the circuitry use din the analog chip in the Victory/Zephyr family of devices in the analog chip used in the Identity and Identity ADx family of devices, and for resizing the Sense and IEGM gain capacitors. |
P910023/S142 7/10/07 Real-Time |
Cadence® Tiered-Therapy Defibrillator System |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for software modifications to the Housecall Plus System software (Receiver Software Model 4000 Version 3.1) which merges the HouseCall receiver 3.0.3 and the Matrix PCS 2.0 software version. |
P910054/S004 7/3/07 135-Day |
Inoue Balloon Catheter |
Toray Industries ( America), Inc. New York , NY 10017 |
Approval for a change to the supplier of the guidewire and stylet bulk material. |
P920015/S037 7/3/07 Real-Time |
Sprint Fidelis Lead Models 6949, 6948, 6931, and 6930 |
Medtronic, Inc. Shoreview , MN |
Approval for design and manufacturing changes to improve the DF-1 leg strength and handling characteristics of Sprint Fidelis leads. |
|
7/11/07 Panel |
VISX STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System |
AMO/VISX, Inc. Santa Clara, CA 95051 |
Approval for the STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System. The device used a 6.0 mm optical zone, an 8.0 mm treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 1) 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision; 2) with myopic astigmatism up to -6.00 D MRSE, with cylinder up to -3.00 D, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; 3) with documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and 4) with a successful pre-operative trial of monovision or history of monovision experience. |
P940034/S017 7/18/07 135-Day |
Gen-Probe® Amplified Mycobacterium Tuberculosis Direct Test |
Gen-Probe, Inc. San Diego , CA 92121 |
Approval for a change to a quality control release specification for the Enzyme Reagent, a component of the Mycobacterium Tuberculosis Direct (MTD) test. |
P950032/S044 7/13/07 Real-Time |
Apligraf® |
Organogenesis, Inc. Canton , MA 02021 |
Approval for a new cell strain, HEP 040, for introduction into production of Apligraf. The device, as modified, will be marketed under the trade name Apligraf and is indicated for the treatment of partial and full thickness chronic venous ulcers. |
P950034/S027 7/11/7 180-Day |
Seprafilm® Adhesion Barrier |
Genzyme Biosurgery Cambridge , MA 02142 |
Approval for labeling changes. The device, as modified, will be marketed under the trade name Seprafilm® Adhesion Barrier and is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder. |
P960058/S057 7/27/07 135-Day |
HiResolution Bionic Ear System (Hi Res90K) |
Advanced Bionics Corporation Sylmar , CA 91342 |
Approval for the revision of the manufacturing specification SOP (MS0037) to include an additional vacuum/backfill cycle. |
P960058/S058 7/2/07 180-Day |
HiResolution Bionic Ear System |
Advanced Bionics Corporation Sylmar , CA 91342 |
Approval for three “vacuum bake air flow enhancements” to the HiRes90K cochlear implant, as follows: 1) The bottom cover shield inside the HiRes90K case was modified from having a “V”-shaped channel to having a larger “U”-shaped channel. 2) Holes were added to the insulating Kapton disc. 3) Slots were implemented inside the feedthrough case. The device, as modified, will be marketed under the trade name HiResolution Bionic Ear System and is indicated for individuals aged 12-months and older with severe-to-profound sensorineural hearing loss to restore a level of auditory sensation via electrical stimulation of the auditory nerve. |
D970012/S034 7/19/07 180-Day |
Ambicor® Inflatable Penile Prosthesis |
American Medical Systems, Inc. Minnetonka , MN 55343 |
Approval for modifications to the physician and patient labeling to summarize the results of the postapproval study. |
P970021/S014 7/6/07 180-Day |
Gynecare Thermachoice III Uterine Balloon Therapy (UBT) System |
Ethicon, Inc. Somerville , NJ 08876 |
Approval for revised professional labeling to include the results of a multi-center study of the Gynecare Thermachoice III Uterine Balloon Therapy (UBT) System. |
P980003/S019 7/24/07 Real-Time |
Chilli II Cooled Ablation Catheter |
Boston Scientific Corporation San Jose , CA 95134 |
Approval for extension of the expiration date (shelf-life) from one-year to three-years for the Chilli II Cardiac Ablation Catheter. |
P980016/S097 7/17/07 135-Day |
Various Families of ICDs & CRT-D Devices |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for an increase in the capacity of the board burn-in chamber. |
P980022/S019 7/11/07 180-Day |
Medtronic MiniMed Continuous Glucose Monitoring System |
Medtronic MiniMed Northridge , CA 91325 |
Approval for a manufacturing site located at Medtronic Mexico, Baja California, Mexico. |
P980050/S026 7/17/07 135-Day |
Various Families of ICDs & CRT-D Devices |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for an increase in the capacity of the board burn-in chamber. |
P990001/S028 7/10/07 Real-Time |
Vitatron C-series (A1 models), Vitatron C-Series (A3 models), Vitatron T-Series, and Vitatron Diva, DEMA, and selection AFm Devices |
Medtronic Cardiac Rhythm Disease Management Shoreview , MN |
Approval for modifications to the Vitatron family application software models that support the Diva, DEMA and Selection AFm 902 devices (VSC02 version 9.1 SR1), C-series devices A1 models (VSF04 version 1.3), C-series devices A3 models (VSF12 version 1.2, and T-series devices (VSF08 version 1.6). The modifications will update the EMI behavior of your device, correct the issue of DA+ inhibition of pacing below the programmed threshold, identify to the user inaccurate coulomb counts, allow the application suite to be split into several application packages, and minor software enhancements. |
P990037/S025 7/17/07 Special |
Vascular Solutions D-Stat Flowable Hemostat |
Vascular Solutions, Inc. Minneapolis , MN 55369 |
Approval for the addition of the following warning to the labeling: “The safety and effectiveness of D-Stat has not been established for use to control bleeding following organ or tissue biopsies. Use of D-Stat in this situation has been reported to result in pain, seizures, bile retention, tissue necrosis, vascular occlusion and death.” |
P990046/S011 7/25/07 Real-Time |
ATS Open Pivot™ Bileaflet Heart Valve Models 500FAXX and 500 DMYY |
ATS Medial, Inc. Minneapolis , MN 555447 |
Approval for a cuff design change. |
P990046/S017 7/23/07 Real-Time |
ATS Open Pivot™ Bileaflet Heart Valve 35 mm Mitral Valve |
ATS Medial, Inc. Minneapolis , MN 555447 |
Approval for a cuff change to add the 35 mm Mitral Valve to the approved mitral valve sizes. |
P990080/S024 7/16/07 180-Day |
TECNIS™ Foldable Acrylic Intraocular Lens, Model ZA9003 |
Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Approval to add an alternate manufacturing site, A.M.O. Puerto Rico Manufacturing, Inc., Anasco, Puerto Rico. |
P000040/S011 7/16/07 Special |
HTA System |
Boston scientific Corp. Marlborough , MA 01752 |
Approval for the inclusion of additional warnings and precautions to minimize burn injuries and to ensure proper handling of the procedure sheath. |
P000054/S010 7/3/07 135-Day |
INFUSE® Bone Graft |
Medtronic, Inc. Memphis , TN 38132 |
Approval fora new test method for the quantitative analysis of polysorbate-80 excipient for the release of rhBMP-2. |
P000058/S021 7/3/07 135-Day |
INFUSE® Bone Graft |
Medtronic, Inc. Memphis , TN 38132 |
Approval fora new test method for the quantitative analysis of polysorbate-80 excipient for the release of rhBMP-2. |
P010014/S015 7/5/07 135-Day |
Oxford® Meniscal Unicompartmental Knee System |
Biomet, Inc. Warsaw , IN 46581 |
Approval for changes to the process specifications for the aqueous cleaning process used during the manufacture of the components of Biomet’s Oxford Meniscal Unicompartmental Knee System. |
P010019/S006 7/26/07 180-Day |
NIGHT & DAY (lotrafilcon A) Soft Contact Lenses for Up to 30 Nights Continuous Wear |
Ciba Vision Corporation Duluth , GA 30097 |
Approval for revised labeling for NIGHT & DAY (lotrafilcon A) Soft Contact Lenses for Up to 30 Nights Continuous Wear. |
P010029/S006 7/11/07 Real-Time |
Euflexxa (1% Sodium Hyaluronate) |
Ferring Pharmaceuticals, Inc. Parsippany , NJ 07054 |
Approval for a syringe tip cap material change from natural rubber to a synthetic rubber formulation. |
P010031/S065 7/17/07 135-Day |
Various Families of iCDs & CRT-D Devices |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for an increase in the capacity of the board burn-in chamber. |
P010038/S014 7/27/07 180-Day |
iCAD Second Look® Computer-Aided Detection System |
iCAD, Inc. Beavercreek , OH 45431 |
Approval for a manufacturing site located at Proven Process Medical Devices, Mansfield, Massachusetts. |
P020004/S019 7/25//07 135-Day |
Gore Excluder® AAA Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff , AZ 860003 |
Approval for the addition of an optional quality control inspection in the graft attach process for the device. |
P020018/S024 7/5/07 180-Day |
36 mm Diameter Zenith® AAA Endovascular Graft/Zenith® Renu™ AAA Ancillary Graft |
Cook, Inc. Bloomington , IN 47402 |
Approval to market the 36 mm Diameter Zenith® AAA Endovascular Graft/Zenith® Renu™ AAA Ancillary Graft |
P030002/S010 7/26/07 Real-Time |
crystalens™ Models AT-50SE and AT-52SE accommodating Intraocular Lenses (IOLs) |
Eyeonics, Inc. Aliso Viejo , CA 92656 |
Approval for the Models AT-50SE and AT-52SE accommodating IOLs used with the Staar MSI-PF/TF injector and MTC-60c cartridge. |
P030006/S014 7/3/07 Real-Time |
Prolieve Thermodilatation® System |
Celsion Corporation Columbia , MD 21046 |
Approval for modification of the User Manual as Revision E. |
P030017/S022 7/18/07 180-Day |
PRECISION™ Spinal Cord Stimulation (SCS) System |
Advanced Bionics Sylmar , CA 91342 |
Approval for an optional surgical tool called the “Introducer”. |
P030047/S003 7/12/07 180-Day |
Cordis PRECISE® OTW 5.5 Fr and 6.0 Fr Nitinol Stent System |
Cordis Corporation Warren , NJ 07059 |
Approval for the Cordis PRECISE® PRO Rx Nitinol Stent System. |
P030054/S049 7/25/07 180-Day |
QuickFlex™ Model 1156T and XL Model 1158T Left Ventricular Pacing Leads |
St. Jude Medical CRMD Sylmar , CA 91342 |
Approval for distal tip modifications to the QuickSite lead family to reduce the length of rigid sections and increase lead flexibility. The device, as modified, will be marketed under the trade name QuickFlex Model 1156T and XL Model 1158T Left Ventricular Pacing Leads. QuickFlex leads are 6 French, transvenous, steroid eluting, bipolar, IS-1 compatible, S-shaped curve, passive fixation leads intended for permanent sensing and pacing of the left ventricle when used with a compatible St. Jude Medical’s biventricular system. |
P040014/S005 7/13/07 135-Day |
IBI Therapy Cardiac Ablation System ERS/1500T RF Generator |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for a change from lot release to parametric release. |
P040037/S004 7/31/07 180-Day |
Gore Viabahn® Endoprosthesis with Heparin Bioactive Surface |
W.L. Gore & Associates, Inc. Flagstaff , AZ 860003 |
Approval or the addition of a heparin coating on the Gore Viabahn® Endoprosthesis, referred to as the Heparin Bioactive Surface. |
P040042/S007 7/13/07 135-Day |
Therapy Dual 8 Cardiac Ablation System |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for a change from lot release to parametric release. |
P040043/S013 7/25//07 135-Day |
Gore TAG Thoracic Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff , AZ 860003 |
Approval for the addition of an optional quality control inspection in the graft attach process for the device. |
P040050/S001 7/27/07 180-Day |
Macroplastique® Implants |
Uroplasty, Inc. Minnetonka , MN 55343 |
Approval for a manufacturing site change from Minneapolis, Minnesota to Minnetonka, Minnesota. |
P050007/S006 7/30/07 Real-Time |
StarClose™ and StarClose™ SE Vascular Closure Systems |
Abbott Vascular Devices Redwood City , CA 94063 |
Approval for design changes to the Pusher Body for both the StarClose™ Vascular Closure System (VCS) and the StarClose™ SE Vascular Closure System ad for the addition of chambers on the interior of the StarClose™ SE Vascular Closure System to improve the retraction of the Thumb Advancer. |
P050018/S002 7/12/07 Real-Time |
AngioSculpt® Scoring Balloon Catheter |
AngioScore, Inc. Fremont , CA 94538 |
Approval for a minor changes to the strain relief and catheter shaft. |
P050033/S001 7/16/07 180-Day |
Cosmetic Tissue Augmentation (CTA) Product, 1 ml |
Anika Therapeutics, Inc. Woburn , MA 01801 |
Approval for: 1) an increase n the buffer concentration of the final product from 12 mM to 50 mM sodium phosphate; 2) the introduction of an antioxidant, i.e., 0.1% sodium metabisulfite, into the final product; and 3) the introduction of an 0.5 ml configuration of Cosmetic Tissue Augmentation Product (CTA). |
P060001/S00 7/17/07 135-Day |
Protégé® GPS and Protégé® RX Carotid Stent System |
ev3, Inc. Plymouth , MN 55442 |
Approval for a change to the manufacturing process: 1) to include an alternate three (3)-pallet sterilization chamber and 2) to reduce the frequency of pyrogen testing. |
P060001/S002 7/17/07 135-Day |
Protégé® GPS and Protégé® RX Carotid Stent System |
ev3, Inc. Plymouth , MN 55442 |
Approval for a change to the manufacturing process to include alternate process challenge devices (PCD). |
P060019/S001 7/13/07 135-Day |
Therapy™ Cool Path™ Cardiac Ablation Catheter and 1500T9 Cardiac Ablation Generator |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for a change from lot release to parametric release. |
P060019/S002 7/17/07 Real-Time |
Therapy™ Cool Path™ Cardiac Ablation Catheter and 1500T9 Cardiac Ablation Generator |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for a change from a shaft containing a proximal braided section and distal non-braided section braided tubing for both proximal and distal sections. |
P060019/S003 7/26/07 Real-Time |
Therapy™ Cool Path™ Cardiac Ablation Catheter and 1500T9 Cardiac Ablation Generator |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for a minor design change which added a volume control to the audible output device to permit the user to vary the volume of the continuous beeping sound made during radiofrequency delivery of power. |
30-Day Notices (135 Day Supplement was not required)
P810006/S028 7/20/07 |
CollaStat® Absorbable Collagen Hemostatic Agents |
Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Change in cleaning manufacturing equipment used in the lyophilization process. |
P840062/S013 7/20/07 |
CollaStat® Absorbable Collagen Hemostatic Agents |
Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Change in cleaning manufacturing equipment used in the lyophilization process. |
P850010/S025 7/20/07 |
CollaStat® Absorbable Collagen Hemostatic Agents |
Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Change in cleaning manufacturing equipment used in the lyophilization process. |
P850089/S056 7/27/07 |
Capsure® SP and Capsure® Z Pacing Leads |
Medtronic, Inc. CRDM Shoreview , MN 55126 |
Change in the molding vendor for the IS-1 Connector Sleeve component from Medtronic Puerto Rico Operations Company to FMI, Inc. |
P880003/S091 7/5/07 |
PTCA Dilation Catheters |
Cordis Corporation Miami Lakes , FL 33014 |
Change in the environmental conditions of the manufacturing facility in the fabrication of balloons for the PTCA Dilation Catheters. |
P880003/S092 7/13/07 |
Cordis PTCA Dilation Catheter |
Cordis Corporation Miami Lakes , FL 33014 |
Change the high-density polyethylene (HDPE) forming tube extrusion process from air extrusion to vacuum extrusion. |
P910023/S143 7/24/07 |
Cadence Family of ICDs |
St. Jude Medical CRMD Sunnyvale , CA 94086 |
Enhancements to the hybrid substrate attachment process. |
P920023/S021 7/27/07 |
Urolume Urethral Stent |
American Medical Systems Minnetonka , MN 55343 |
Change in the label generation system for the device. |
P930039/S023 7/27/07 |
Surefix Pacing Leads |
Medtronic, Inc. CRDM Shoreview , MN 55126 |
Change in the molding vendor for the IS-1 Connector Sleeve component from Medtronic Puerto Rico Operations Company to FMI, Inc. |
P950037/S052 7/25/07 |
Philos, Axios, Protos, Philos II and Cylos Pacemakers |
Biotronik, Inc. Lake Oswego , OR 97035 |
Change where the cables are packaged. |
P960028/S022 7/10/07 |
ReZoom Multifocal Intraocular Lenses (IOLs) |
Advanced Medical Optics Santa Ana , CA 92705 |
Reduction of the total process time. |
D970003/S088 7/5/07 |
INSINIA Family of Devices |
Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Modification of the cleaning process recipe for INSIGNIA hybrids. |
D970003/S089 7/24/07 |
INSIGNIA and NEXUS Pacemakers |
Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Change in supplier for the crystal oscillator component. |
D970012/S040 7/27/07 |
AMS 700 Inflatable Penile Prosthesis and Ambicor Inflatable Penile prosthesis |
American Medical Systems Minnetonka , MN 55343 |
Change in the label generation system for the device. |
D970012/S042 7/31/07 |
AMS 700™ Penile Prosthesis |
American Medical Systems Minnetonka , MN 55343 |
Change in the manufacturing process to add another package heat sealer. |
P980023/S028 7/25/07 |
Linox S and Linox T ICD Leads |
Biotronik, Inc. Lake Oswego , OR 97035 |
Change where the cables are packaged. |
P980040/S016 7/10/07 |
Sensar Acrylic IOLs |
Advanced Medical Optics Santa Ana , CA 92705 |
Reduction of the total process time. |
P990020/S026 7/3/07 |
AneuRx AAAdvantage Stent Graft with Xcelerant Delivery system |
Medtronic Vascular Santa Rosa , CA 95403 |
Implementation of an inspection fixture to aid in the current inspection process to confirm bond integrity. |
P990080/S025 7/10/07 |
Tecnis® Acrylic IOLs |
Advanced Medical Optics Santa Ana , CA 92705 |
Reduction of the total process time. |
P990081/S006 7/24/07 |
Pathway® HER-2/Neu Control Slides |
Ventana Medical Systems, Inc. Tucson , AZ 85737 |
Change in acceptance testing for the control slide lot release testing. |
P000025/S024 7/24/07 |
COMBI 40+ Cochlear Implant System |
MED-EL Elektro-Medizinische GmbH Innsbruck , Austria A06020 |
Addition of two cleanroom modules to provide additional work space for electrode manufacturing. |
P000025/S025 7/24/07 |
COMBI 40+ Cochlear Implant System |
MED-EL Elektro-Medizinische GmbH Innsbruck , Austria A06020 |
Removal of the pre-cleaning step for the device. |
P000029/S027 7/10/07 |
Deflux® Injectable Gel |
Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Change in shelf life for a filter used in the manufacturing process of the device. |
P000032/S021 7/27/07 |
Her Option Cryoablation Therapy System |
American Medical Systems Minnetonka , MN 55343 |
Change in the label generation system for the device. |
P000043/S018 7/27/07 |
TherMatrx Office Thermotherapy System |
American Medical Systems Minnetonka , MN 55343 |
Change in the label generation system for the device. |
P000053/S009 7/27/07 |
AMS 800 Artificial Urinary Sphincter |
American Medical Systems Minnetonka , MN 55343 |
Change in the label generation system for the device. |
P010020/S005 7/27/07 |
Acticon Neosphincter Artificial Bowel Sphincter |
American Medical Systems Minnetonka , MN 55343 |
Change in the label generation system for the device. |
P020001/S001 7/3/07 |
STAN® S31 Fetal Heart Monitor TOCO Transducer |
Neoventa Medical AB Molndal , Sweden |
Redesign of the wiring arrangement within the transducer component of the system. |
P020004/S025 7/5/07 |
GORE EXCLUDER® AAA Endoprosthesis |
W.L. Gore & Associates Flagstaff , AZ 860003 |
Change to the method of marking of device size and lot number on the delivery catheter for the device. |
P020026/S037 7/11/07 |
Cordis CYPHER Sirolimus-eluting Coronary Stent |
Cordis Corporation Miami , FL 33012 |
New receiving inspection analytical test method for nitrogen, liquid nitrogen, and argon through gas chromatography (GC) using a thermal conductivity detector (TCD) for the device. |
P030006/S015 7/10/07 |
Prolieve Thermodilatation® System |
Celsion Corporation Columbia , MN 21046 |
Six changes: 1) revised work in progress management procedure; 2) a process document change; 3) change in the frequency of a maintenance schedule; 4) change in the identification of a part; 5) change in the tolerance of a part; and 6) change in a subassembly test. |
P030039/S005 7/24/07 |
CoSeal Surgical Sealant |
Baxter Healthcare Corporation McGaw Park , IL 60085 |
Expansion of the ISO Class 7 Cleanroom and the installation of a larger water delivery pump. |
P030054/S059 7/24/07 |
Cadence Family of ICDs |
St. Jude Medical CRMD Sunnyvale , CA 94086 |
Enhancements to the hybrid substrate attachment process. |
P040024/S010 7/11/07 |
Restylane Injectable Gel |
Medicis Aesthetics Scottsdale , AZ 85258 |
Change in a testing laboratory. |
P040024/S011 7/6/07 |
Restylane Injectable Gel |
Medicis Aesthetics Scottsdale , AZ 85258 |
Change to one test method used in the laboratory. |
P050023/S005 7/25/07 |
Kronos LV-T CRT-D and Lumax Family of ICDs |
Biotronik, Inc. Lake Oswego , OR 97035 |
Change where the cables are packaged. |
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 49
Summary of PMA Originals Under Review
Total Under Review: 74
Total Active: 33
Total On Hold: 41
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 390
Total Active: 221
Total On Hold: 169
Number Greater Than 180 Days: 20
Summary of All PMA Submissions Received
Originals: 3
Supplements: 85
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 49
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 160.0
FDA Time: 116.2 Days MFR Time: 43.8 Days
Updated August 16, 2007
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