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PMA Final Decisions Rendered for September 2000 |
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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.
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APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
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9/5/00 |
Medstone STS™ Lithotripter for the Treatment of Symptomatic, Solitary, Radiolucent, Non-Calcified Gallstones |
Medstone International, Inc. Aliso Viejo, CA 92656 |
Approval for the Medstone STS™ Lithotripter in conjunction with Actgall®. When used with the drug, this device is indicated for the treatment of symptomatic, solitary, radiolucent, non-calcified gallstones (between 4 and 20 mm in maximum diameter) in adult patients for whom surgical removal of the gallbladder is medically contraindicated and in symptomatic high-risk patients who have actively refused surgery. Combination therapy consists of 1) administration of Actigall® (8-10 mg/kg/day) for at least two weeks pre-lithotripsy, 2) lithotripsy treatments of up to 2000 24 kV shocks, and 3) continued administration of Actigall® until a stone-free state is achieved. |
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9/19/00 |
DTU-one Ultrasound Scanner |
Osteometer MediTech, Inc. Hawthorne, CA 90250 |
Approval for the DTU-one Ultrasound Scanner. The DTU-one is intended to perform quantitative ultrasound measurement of the calcaneus (the heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid to the physician in diagnosis of osteoporosis (T-score) and in the determination of fracture risk in men and women. The measurement may also be used in Caucasian women to aid in the detection of medical conditions, other than age-related bone loss, that lead to reduced bone density. |
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9/25/00 |
TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System |
Cordis Neurovascular, Inc. Miami Lakes, FL 33014 |
Approval for the TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System. The device is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when presurgical devascularization is desired. |
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9/8/00 |
Bayer Immuno 1™ complexed PSA assay |
Bayer Corporation Tarrytown, NY 10591 |
Approval for the Bayer Immuno 1™ complexed PSA assay. This in vitro device is intended to quantitatively measure complexed prostate-specific antigen (cPSA) in human serum on the Bayer Immuno 1™ system. This device is indicated for the measurement of serum complexed PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Biopsy of the prostate is required for the diagnosis of prostate cancer. This device is further indicated as an aid in the management (monitoring) of prostate cancer patients. This diagnostic method is not intended for use on any other system. |
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9/29/00 |
Phylax AV Implantable Cardioverter Defibrillator with Program Software (I-GAV.2.U) |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Phylax AV ICD System including the Pulse Generator, Model number 122 382 and Phylax AV Software Cartridge SWM 1000/I-GAV.2.U, Model number 128 814. This device is indicated for use in patients who are at high risk of sudden death due to ventricular arrhythmias and have experienced one or more of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmia 2) recurrent, poorly tolerated sustained ventricular tachycardia (VT). NOTE: The clinical outcome for hemodynamically stable, sustained-VT patients is not fully known. Safety and effectiveness studies for this indication have not been conducted. |
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9/29/00 |
BiodivYsio™ AS PC (phosphorylcholine) Coated Stent and Delivery System |
Biocompatibles Cardiovascular, Inc. San Jose, CA 95113 |
Approval for the BiodivYsio™ AS PC (phosphorylcholine) Coated Stent and Delivery System. The device is intended for use in subjects with symptomatic ischemic heart disease due to de novo native coronary artery lesions (length £ 25 mm) with a reference vessel diameter ranging from ³ 3.0 mm to £ 4.0 mm and intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present. |
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9/29/00 |
Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators |
Ortho-Clinical Diagnostics Rochester, NY 14626 |
Approval for the Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators. The device is indicated for: The qualitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum using the Vitros Eci Immunodiagnostic System. Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. |
PMA/PDP SUPPLEMENTAL APPROVALS | |||
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME | DEVICE DESCRIPTION / INDICATIONS |
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N17752/S037 9/18/00 180-Day |
SOFTMATE II, HYDROCURVE II & HYDROCURVE II Aphakic (Bufilcon A) Extended Wear Soft Hydrophilic) Contact Lens |
Wesley Jessen Corporation Des Plaines, IL 60018 |
Approval for the manufacturing facility located at Wesley Jessen, Inc., Cidra, Puerto Rico. |
|
N17987/S028 9/18/00 180-Day |
CSI™ (crofilcon A) Extended Wear Soft (Hydrophilic) 14.8 diameter Contact Lens |
Wesley Jessen Corporation Des Plaines, IL 60018 |
Approval for the manufacturing facility located at Wesley Jessen, Inc., Cidra, Puerto Rico. |
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P830045/S071 9/7/00 180-Day |
Leads, Defibrillators and Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Approval for the alternate manufacturing facility at InnoMedica, Inc., Minneapolis, Minnesota and the alternate sterilization facility at Steris Isomedix, Minneapolis, Minnesota. |
|
P830060/S049 9/25/00 180-Day |
AICD Leads, Pacing Leads and Lead Accessories |
Guidant Corporation St. Paul, MN 55112 |
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at Guidant Puerto Rico, Dorado, Puerto Rico. |
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P850035/S025 9/27/00 180-Day |
SpF® Implantable Bone Growth Stimulator |
EBI, L.P. Parsippany, NJ 07054 |
Approval for revised labeling based on the findings of the post-approval study for the SpF® Implantable Bone Growth Stimulator. |
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P850057/S006 9/18/00 180-Day |
Custom Tinted (Bufilcon A) Extended Wear Soft (Hydrophilic) Contact Lens |
Wesley Jessen Corporation Des Plaines, IL 60018 |
Approval for the manufacturing facility located at Wesley Jessen, Inc., Cidra, Puerto Rico. |
|
P850079/S037 9/25/00 180-Day |
Frequency Colors, Frequency Aspheric Colors and Frequency Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear |
CooperVision, Inc. Scottsville, NY 14546 |
Approval for the Frequency Colors contact lenses in spherical, aspheric and toric configurations. The devices, as modified, will be marketed under the trade names Frequency Colors, Frequency Aspheric Colors and Frequency Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear. The Frequency Colors, Frequency Aspheric Colors and Frequency Toric Colors lenses are indicated for extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care practitioner. They are also indicated to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The Frequency Colors and Frequency Aspheric Colors may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The Frequency Toric Colors lenses may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. |
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P860019/S160 9/27/00 180-Day |
Boston Scientific Scimed MAVERICK™ Monorail™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Approval for the Boston Scientific Scimed MAVERICK™ Monorail™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (9, 12, 25, and 30 mm lengths with balloon diameters of 2.0 – 4.0 mm in ¼ mm increments, and 15 and 20 mm lengths with balloon diameters of 1.5 mm and 2.0 – 4.0 mm in ¼ mm increments). The MAVERICK™ Monorail™ PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The MAVERICK™ Monorail™ PTCA Catheter (2.25 – 4.0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents. |
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P880003/S081 9/21/00 180-Day |
NC RAPTOR Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheters |
Cordis Corporation Miami, FL 33102 |
Approval for the NC Raptor PTCA Catheter (balloon diameters ranging from 2.25 mm to 4.0 mm and lengths ranging from 10 mm to 30 mm). The NC Raptor PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Models with the following balloon sizes (length x diameter) are also indicated for the post-delivery expansion of balloon expandable stents: 2.25 mm x 10 mm to 15 mm; 3.0 mm x 20 mm to 30 mm; and 4.0 mm x 15 mm to 30 mm. |
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P880006/S033 9/7/00 180-Day |
Leads, Defibrillators and Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Approval for the alternate manufacturing facility at InnoMedica, Inc., Minneapolis, Minnesota and the alternate sterilization facility at Steris Isomedix, Minneapolis, Minnesota |
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P880086/S077 9/7/00 180-Day |
Leads, Defibrillators and Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Approval for the alternate manufacturing facility at InnoMedica, Inc., Minneapolis, Minnesota and the alternate sterilization facility at Steris Isomedix, Minneapolis, Minnesota. |
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P880098/S011 9/6/00 180-Day |
Menicon SF-P (melafocon A) RGP Contact Lens |
Menicon Company, Ltd. Wilmington, MA 01887 |
Approval of procedures to add lens finishing laboratories as manufacturers and distributors of Class III RGP Extended Wear Contact Lenses. |
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P890012/004 9/12/00 180-Day |
Gentle Touch™ UV (netrafilcon A) Soft (hydrophilic) Contact Lens For Extended Wear (cast-molded and visitint with D & C Green #6) |
Wesley Jessen Corporation Des Planes, IL 60018 |
Approval for 1) a change in manufacturing method from lathe-cut to cast-molded; 2) a change in handling tint from Vat Dyes to D & C Green #6; 3) to add an ultraviolet absorber into netrafilcon A lens material; 4) an alternate manufacturing site at Wesley Jessen PBH, Ltd., Southampton, United Kingdom; 5) modification to the indications for use including the sentence "Gentle Touch™ UV (netrafilcon A) Soft (hydrophilic) Contact Lenses help to protect against the transmission of harmful UV radiation to the cornea and into the eye"; and 6) modification of the NOTE and WARNING in labeling. |
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P890061/S013 9/25/00 180-Day |
AICD Leads, Pacing Leads and Lead Accessories |
Guidant Corporation St. Paul, MN 55112 |
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at Guidant Puerto Rico, Dorado, Puerto Rico. |
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P890064/S008 9/12/00 180-Day |
HCS HPV, HCII HPV |
Digene Corporation Beltsville, MD 20705 |
Approval for a manufacturing site located at Digene Corporation, Gaithersburg, Maryland. |
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P900009/S011 9/8/00 Real-Time |
Exogen 2000® Sonic Accelerated Fracture Healing System |
Exogen, Inc. Rockville, Maryland 20852 |
Approval for a change in the conditions of approval to terminate the requirement for a prescription registry. |
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P900066/S004 9/5/00 Special |
Perfluoropropane (C3F8) for Pneumatic Retinopexy |
Scott Medical Products Plumsteadville, PA 18949 |
Approval for a change to the toxicity test protocol to increase the number of samples to be tested from each production lot of perfluoropropane from one sample per lot to three samples per lot. |
|
P900070/S027 9/7/00 180-Day |
Leads, Defibrillators and Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Approval for the alternate manufacturing facility at InnoMedica, Inc., Minneapolis, Minnesota and the alternate sterilization facility at Steris Isomedix, Minneapolis, Minnesota. |
|
P910023/S048 9/7/00 180-Day |
Leads, Defibrillators and Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Approval for the alternate manufacturing facility at InnoMedica, Inc., Minneapolis, Minnesota and the alternate sterilization facility at Steris Isomedix, Minneapolis, Minnesota. |
|
P910073/S033 9/12/00 Real-Time |
Model 6952 Lead Extender |
Guidant Corporation St. Paul, MN 55112 |
Approval for internal component changes to the IS-1 connector terminal of the Model 6952 Lead Extender. |
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P910073/S034 9/25/00 180-Day |
AICD Leads, Pacing Leads and Lead Accessories |
Guidant Corporation St. Paul, MN 55112 |
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at Guidant Puerto Rico, Dorado, Puerto Rico. |
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P910077/S033 9/25/00 180-Day |
AICD Leads, Pacing Leads and Lead Accessories |
Guidant Corporation St. Paul, MN 55112 |
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at Guidant Puerto Rico, Dorado, Puerto Rico. |
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P940010/S009 9/29/00 180-Day |
OPTIGUIDE™ Photodynamic Therapy Fiber Optic Treatment System, Series DCYL 4 |
QLT Photo Therapeutics, Inc. Washington, DC 20004 |
Approval for modification of the OPTIGUIDE Fiber Optic Diffuser to include use of a sherile, single use sheath with a reusable diffusing fiber optic. The device, as modified, will be marketed under the trade name OPTIGUIDE Photodynamic Therapy Fiber Optic Treatment System, Series DCYL 4 and is indicated for use in Photodynamic Therapy with PHOTOFRIN® (porfimer sodium) for injection for the: 1) palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physicians, cannot be satisfactorily treated with Nd:YAG laser therapy, 2) reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC), 3) treatment of microinvasive endobronchial NSCLC in patients of whom surgery and radiotherapy are not indicated. |
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P940015/S005 9/12/00 Real-Time |
Synvisc® hylan G-F 20 |
Biomatrix, Inc. Ridgefield, NJ 07657 |
Approval for a labeling change extending the time of treatment effect to 26 weeks. |
|
P940040/S001 9/12/00 180-Day |
Roche Amplicor Mycobacterium Tuberculosis Test |
Roche Molecular Systems, Inc. Pleasanton, CA 94566 |
Approval for current facility plans, revised Batch Records, revised QC specifications, revised Packaging Orders and revised labels. |
|
P950001/S008 9/25/00 180-Day |
AICD Leads, Pacing Leads and Lead Accessories |
Guidant Corporation St. Paul, MN 55112 |
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at Guidant Puerto Rico, Dorado, Puerto Rico. |
|
9/28/00 180-Day |
Cordis Webster Diagnostic/Ablation Deflectable Tip Catheters and NAVI-STAR® Diagnostic/Ablation Deflectable Tip Catheters |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for an alternate manufacturing site located at Biosense Webster, Inc., Irwindale, California. |
|
P950015/S007 9/27/00 Real-Time |
The Heart Laser™ CO2 System for Transmyocardial Revascularization |
PLC Medical Systems, Inc. Franklin, MA 02038 |
Approval to modify the existing post-approval study to no longer require study enrollment at new sites, and to limit study participation to those (existing) sites which have enrolled patients. |
|
P950022/S010 9/7/00 180-Day |
Leads, Defibrillators and Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Approval for the alternate manufacturing facility at InnoMedica, Inc., Minneapolis, Minnesota and the alternate sterilization facility at Steris Isomedix, Minneapolis, Minnesota. |
|
P950022/S011 9/25/00 180-Day |
TVL® Leads System |
St. Jude Medical Sunnyvale, CA 94086 |
Approval for an alternate manufacturing facility for lead reprocessing at St. Jude Medical, Sylmar, California. |
|
P950029/S012 9/13/00 Real-Time |
Brio Pacemaker Models DR212/D220/DR222 and Talent Pacemaker Models DR213/DR223 |
ELA Medical Plymouth, MN 55441 |
Approval for changes to the implant and programmer software for the Talent and Brio families of pacemakers. |
|
P950037/S015 9/5/00 Real-Time |
Philos Pulse Generator Family |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the activation of the PMT management and AV delay features in the Philos Pulse Generator Family, modifications to the programmer software resulting in version B-K01.0.U, the PGH 3000 programmer head, and the VK-92 programmer printer cable. |
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P960004/S015 9/25/00 180-Day |
AICD Leads, Pacing Leads and Lead Accessories |
Guidant Corporation St. Paul, MN 55112 |
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at Guidant Puerto Rico, Dorado, Puerto Rico. |
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P960006/S004 9/25/00 180-Day |
AICD Leads, Pacing Leads and Lead Accessories |
Guidant Corporation St. Paul, MN 55112 |
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at Guidant Puerto Rico, Dorado, Puerto Rico. |
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P960013/S008 9/7/00 180-Day |
Leads, Defibrillators and Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Approval for the alternate manufacturing facility at InnoMedica, Inc., Minneapolis, Minnesota and the alternate sterilization facility at Steris Isomedix, Minneapolis, Minnesota. |
|
P960025/S005 9/8/00 180-Day |
Lumbar I/F Cage with VSP Spine System |
Dupuy AcroMed Raynham, MA 02767 |
Approval for changing the material of the I/F Cage device component. |
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P960030/S007 9/7/00 180-Day |
Leads, Defibrillators and Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Approval for the alternate manufacturing facility at InnoMedica, Inc., Minneapolis, Minnesota and the alternate sterilization facility at Steris Isomedix, Minneapolis, Minnesota. |
|
P960036/S003 9/25/00 180-Day |
Memory Lens® UV Absorbing Hydrophilic Posterior Chamber IOL |
Ciba Vision Corporation Duluth, GA 30097 |
Approval to modify the European phase-in study described in supplement 2 dated August 25, 2000 for the Memory Lens®. |
|
P960043/S026 9/29/00 Real-Time |
The Closer S™ 6 Fr. Suture Mediated Closure (SMC) System |
Perclose, Inc. Redwood City, CA 94063 |
Approval for The Closer S™ 6 Fr. Suture Mediated Closure (SMC) System. The device, as modified, is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic catheterization procedures using 5 to 6 Fr. Sheaths. The Closer S™ 5 Fr. Suture Mediated Closure (SMC) System reduces the times to hemostasis, ambulation (5 meters or 16 feet) and discharge in patients who have undergone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations in the device labeling). |
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P960057/S011 9/27/00 Special |
ADCON®-L Adhesion Control in a Barrier gel |
Gliatech, Inc. Cleveland, OH 44122 |
Approval for modifications to procedures used for the manufacture and testing of the device. The device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis. |
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P960058/S006 9/5/00 180-Day |
CLARION® Multi-Strategy Cochlear Implant (Pediatric) Electrode Positioner |
Advanced Bionics® Corporation Sylmar, CA 91342 |
Approval for the CLARION® Multi-Strategy Cochlear Implant with the Electrode Positioner for pediatric uses. |
|
P970015/S010 9/28/00 Panel-Track |
LT-CAGE™ Lumbar Tapered Fusion Device |
Sofamor Danek USA Memphis, TN 38132 |
Approval for tapered version of the INTERFIX™ Threaded Fusion Device. The device, as modified, will be marketed under the trade name LT-CAGE™ Lumbar Tapered Fusion Device and is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. LT-CAGE implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the LT-CAGE™ Lumbar Tapered Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the LT-CAGE™. |
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P970020/S021 9/8/00 180-Day |
ACS Multi-Link RX and OTW Ultra™ Coronary Stent Systems |
Guidant Corporation Santa Clara, CA 95052 |
Approval for the ACS Multi-Link RX and OTW Ultra™ Coronary Stent Systems. The devices are indicated for improving coronary lumen diameter in the following: 1) Patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary artery lesions (length £ 25 mm) with a reference vessel diameter of 3.5 mm to 5.0 mm; and 2) Treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (£ 35 mm length) with reference diameters in the range of 3.5 mm to 5.0 mm. Long term outcome for this permanent implant is unknown at present. Note: the 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure. |
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9/22/00 Panel Track |
LADARVision® Excimer Laser System |
Summit Autonomous Corporation Orlando, FL 32826 |
Approval for the LADARVision® Excimer Laser System. The device is indicated for laser in-situ keratomileusis (LASIK) treatments: 1) for the reduction or elimination of refractive error of less than or equal to +6.00D of sphere and –6.00D of cylinder at the spectacle plane (hyperopia with or without astigmatism and mixed astigmatism); 2) in subjects with documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0.50D for corrections up to +6.00D SE; and 3) in subjects who are 21 years of age or older. |
|
P990013/S001 9/25/00 180-Day |
COLLAMER™ Ultraviolet Absorbing Posterior Chamber Intraocular Lens (IOL) |
STAAR Surgical Company Monrovia, CA 91016 |
Approval for a new manufacturing facility at STAAR Surgical Co., Monrovia, California. |
|
P990018/S001 9/6/00 180-Day |
Menicon Z (tisilfocon A) RGP Contact Lens |
Menicon Company, Ltd. Wilmington, MA 01887 |
Approval of procedures to add lens finishing laboratories as manufacturers and distributors of Class III RGP Extended Wear Contact Lenses. |
|
P990019/S001 9/26/00 180-Day |
BUL-U™ Model 4170 |
Guidelines, Inc. Miramar, FL 33025 |
Approval for the modified version of the BLU-U™ blue light photodynamic therapy illuminator. The device, as modified, will be marketed under the trade name BLU-U™ Model 4170. |
|
P990025/S001 9/28/00 180-Day |
Cordis Webster Diagnostic/Ablation Deflectable Tip Catheters and NAVI-STAR® Diagnostic/Ablation Deflectable Tip Catheters |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for an alternate manufacturing site located at Biosense Webster, Inc., Irwindale, California. |
|
P990052/S001 9/21/00 Real-Time |
Vibrant D® Soundbridge™ System (Vibrating Ossicular Prosthesis Model 502, Audio Processor D Model 304, Programmer Model 700, Audio Processor Adapter) |
Symphonix Devices, Inc. San Jose, CA 95131 |
Approval for incorporation of a releasable battery door for the Audio Processor D (Model 304). |
| 30-DAY NOTICES (135 Day Supplement Was Not Required) | |||
| APPLICATION NUMBER & LTR DATE | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | COMMENTS |
|
P900056/S054 9/18/00 |
Rotablator Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052 |
Change to the manufacturing process test specification for the minimum dynamic distal flow rate. |
|
P900060/S021 9/5/00 |
Sulzer Carbomedics Carbo-Seal® Ascending Aortic Prosthesis |
Sulzer Carbomedics, Inc. Austin, TX 78752 |
Change to a larger capacity chamber used to sterilize the Sulzer Carbomedics Carbo-Seal® Ascending Aortic Prosthesis. This larger capacity chamber is located at the facility identified as Sulzer Vascutek located in Scotland. |
Summary of PMA Originals & Supplements Approved
Originals: 7
Supplements: 49
Summary of PMA Originals Under Review
Total Under Review: 76
Total Active: 38
Total On Hold: 38
Number Greater Than 180 Days: 0
Summary of PMA Supplements Under Review
Total Under Review: 183
Total Active: 99
Total On Hold: 84
Number Greater Than 180 Days: 0
Summary of All PMA Submissions Received
Originals: 4
Supplements: 34
Summary of PMA Supplement Approval/Denial Decision Times
Number of Approvals: 49
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 114.6
FDA Time: 67.4 Days MFR Time: 47.2 Days
Updated 1/12/2001
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