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PMA Final Decisions Rendered for April 2001 |
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 |
DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
4/20/01 |
BAK/Cervical (BAK/C®) Interbody Fusion System |
Sulzer Spine-Tech Minneapolis, MN 55439 |
Approval for the BAK/Cervical (BAK/C®) Interbody Fusion System. The device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is definced as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. BAK/C implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. |
4/5/01 |
CeeOn Edge Foldable Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens – Model 911A |
Pharmacia & Upjohn Company Pickerington, OH 43147 |
Approval for the CeeOn Edge Foldable Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens – Model 911A. The device is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification. The lens is intended to be placed in the capsular bag. |
4/20/01 |
HerOption Uterine Cryoblation Therapy System |
CryoGen, Inc. San Diego, CA 92121 |
Approval for the HerOption Uterine Cryoblation Therapy System. The device is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete. |
4/20/01 |
Hydro ThermAblator® Endometrial Ablation System |
BEI Medical Systems Teterboro, NJ 07608 |
Approval for the Hydro ThermAblator® Endometrial Ablation System. The device is intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom child bearing is complete. |
4/27/01 |
Vitros Immunodiagnostic Products HBsAg Reagent Pack, Vitros Immunodiagnostic Products Confirmatory Kit, and Vitros Immunodiagnostic Products Calibrator |
Ortho-Clinical Diagnostics Rochester, NY 14626 |
Approval for the Vitros Immunodiagnostic Products HBsAg Reagent Pack, Vitros Immunodiagnostic Products Confirmatory Kit, and Vitros Immunodiagnostic Products Calibrator. The Vitros Immunodiagnostics HBsAg Reagent Pack is indicated for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (heparin, EDTA, and sodium citrate) using the Vitros ECi Immunodiagnostic System. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B. In addition, this assay may be used to screen for hepatitis B infection in pregnant women to identify neonates who are at high risk of acquiring HBV during the perinatal period. The Vitros Immunodiagnostic Products HBsAg Calibrator is indicated for use in the calibration of the Vitros Immunodiagnostic System for the qualitative in vitro determination of hepatitis B surface antigen (HBsAg) in human serum or plasma (heparin, EDTA, and sodium citrate) using Vitros HBsAg Reagent Packs. The Vitros HBsAg Calibrator has been validated for use only on the Vitros System with the Vitros Immunodiagnostic Products HBsAg Reagent Pack. Refer to the Vitros HBsAg Reagent Pack instructions for use for further details. The Vtiros HBsAg Confirmatory Kit is indicated for the qualitative confirmation of hepatitis B surface antigen (HBsAg) in human serum and plasma (heparin, EDTA, and sodium citrate) specimens that have been found to be repeatedly reactive using the Vitros Immunodiagnostic Products HBsAg Reagent Pack and the Vitros Immunodiagnostic Products HBsAg Calibrator. The Vitros HBsAg Confirmatory Kit is for use with the Vitros ECi Immunodiagnostic System. |
4/18/01 |
Staar Surgical Company STAARVISC II Sodium Hyaluronate |
Anika Therapeutics, Inc. Woburn, MA 01801 |
Approval for reference rights to P810025, and for Staar Surgical Company to distribute the sodium hyaluronate under the tradename STAARVISC II. The device is indicated for use during surgery in the anterior and posterior segments of the human eye. Procedures include: Cataract extraction, Intraocular lens (IOL) implantation, Corneal transplantation surgery, Glaucoma filtering surgery and Surgical procedures to reattach the retina. STAARVISC II is designed to create and maintain anterior chamber depth and visibility, protect corneal endothelial cells and other intraocular tissues, minimize interactions between tissues during surgical manipulation, and act as a vitreous substitute during retinal reattachment surgery. STAARVISC II also preserves tissue integrity and good visibility when used to fill the anterior and posterior segments of the eye following open sky procedures. |
PMA SUPPLEMENTAL APPROVALS |
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APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
4/12/01 180-Day |
ACUVUE® 2 COLOURS Brand (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker |
Vistakon, Division of Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32216 |
Approval for etafilcon A soft (hydrophilic) contact lens for extended wear with UV blocker and the following listed color additives: iron oxide black, iron oxide brown, iron oxide red, iron oxide yellow, titanium dioxide, phthalocyaninato (2-) copper, phthalocyanine green and vat orange 1. The device will be marketed with the following trade names and indications: The ACUVUE® 2 COLOURS Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less. The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D of astigmatism or less. The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The ACUVUE® 2 COLOURS Contact Lenses may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "Wearing Schedule.") When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only. |
P830055/S075 4/17/01 180-Day |
LCS® Total Knee System |
DePuy Orthopaedics, Inc Warsaw, IN 46581 |
Approval for a manufacturing site located at Cycam, Inc., Houston, Pennsylvania. |
P840068/S041 4/30/01 Real-Time |
Vigor Model 2880 v5.2 Software |
Guidant Corporation St. Paul, MN 55112 |
Approval for the Vigor Model 2880 v5.2 Software. |
P850051/S056 4/18/01 Real-Time |
Premier Pacing System |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for the Premier Pacing System, including the Premier Model 8081 VVI Pacemaker, the CapSure Model 4003M Endocardial Lead and the Model 9884 Software for the Model 9790 and 9790C Programmers. |
P890043/S035 4/6/01 180-Day |
FLEXI-CUT Direction Debulking System |
Guidant Corporation Temecula, CA 92589 |
Approval for the FLEXI-CUT Direction Debulking System. The FLEXI-CUT Direction Debulking System is indicated for use in coronary artery disease accessible to DCA (Directional Coronary Atherectomy), generally in the proximal or mid-portion of coronary vessels. It can be used alone or in conjunction with other coronary interventional devices. DCA is intended to improve coronary luminal diameter by mechanically shaving and removing atherosclerotic material from the diseased vessel. |
P890055/S012 4/24/01 Real-Time |
Device: Arrow OR Pump Heater & AP-07009 Flex Tip Plus Intraspinal Kit |
Arrow International Walpole, MA 02081 |
Approval for the addition of: 1) an OR Pump Heater (AP-09100) and Drape (AP-09150) as an option to the traditional water bath; 2) a Micropipette OR Prep Kit (AP-07004) for the measurement of flow from the implantable pump prior to implantation; and 3) accessories to the Intraspinal Kit (AP-07009), including an additional needle and both winged and traditional catheter anchors. |
P900033/S005 4/30/01 Real-Time |
INTEGRA® Artificial Skin, Dermal Regeneration Template |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for a change in the trade name. The device will be marketed under the trade name INTEGRA® Dermal Regeneration Template and is indicated for the post-excisional treatment of life-threatening full-thickness or deep partial-thickness thermal injury where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. |
P900043/S026 4/6/01 Real-Time |
Bx VELOCITY Stent on RaptorRail Stent Delivery System (RX) |
Cordis Corporation Warren, NJ 07059 |
Approval for a modified stent/delivery system. The device, as modified, will be marketed under the trade name Bx VELOCITY Stent on RaptorRail Stent Delivery System (RX) and is indicated for improving coronary luminal diameter in the treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (£ 30 mm in length) with reference diameters in the range of 2.25 mm to 4.00 mm. |
P900056/S062 4/17/01 180-Day |
Rotablator® Rotational Angioplasty System Guide Wires |
Boston Scientific Corporation Redmond, WA 98052 |
Approval for an additional manufacturing site located at Boston Scientific Miami Technology Center (BSMTC), Miami, Florida. |
P910068/S001 4/4/01 180-Day |
Vitreon® Intraocular Fluid (Perfluoroperhydrophenanthrene) |
Vitrophage, Inc. Lyons, IL 60534 |
Approval for 1) manufacturing site change: the new site for manufacturing the bulk medical grade Perfluoroperhydrophenanthrene (APF-215M) will be at FluoroMed, L.P. (FMLP), Round Rock, Texas; 2) manufacturing change: APF-215M will me manufactured from perfluoroperhydrophenanthrene raw material instead of from phenanthrene raw material; and 3) APF-215M specification change regarding testing parameter for lower boiling components. |
P920032/S006 4/6/01 180-Day |
Model 4553 and 4570 MICRO-PACE Dual Chamber, DDD, Temporary Cardiac Pacemakers |
PACE Medical, Inc. Waltham, MA 02451 |
Approval to modify the temporary pacemakers by replacing the zener diodes used for protecting the internal electronics from high voltage transients with a transient voltage suppressor. |
4/27/01 Panel Track |
VISX STAR S2 and S3 Excimer Laser Systems |
VISX, Inc. Santa Clara, CA 95051 |
Approval for the VISX STAR S2 and S3 Excimer Laser Systems. The devices are indicated for laser in-situ keratomileusis (LASIK) treatments: 1) in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and 2) in patients 21 years of age or older in treatments for the reduction of elimination of naturally occurring hyperopia between +05 and +5.0 D sphere at the spectacle plane with or without refractive astigmatism up to +3.0 D, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. |
P940007/S006 4/2/01 180-Day |
Silicone Posterior Chamber Intraocular Lens, Model 912 |
Pharmacia & Upjohn Company Pickerington, OH 43147 |
Approval for sterilizing the silicone posterior chamber intraocular lens, Model 912, at the facility in Groningen, The Netherlands and for changes in the sterilization cycle parameters for Model 912 from 100% ethylene oxide (EtO) to 20 % EtO/80% carbon dioxide. |
P940008/S016 4/25/01 Special |
Intermedics MICRON ICD Models 101-05, 101-05ST, 101-09, 101-09ST, 101-10 and 101-10A |
Guidant Corporation St. Paul, MN 55112 |
Approval for labeling changes to the follow-up indicators reflecting battery longevity. |
P940031/S026 4/30/01 Real-Time |
Vigor Model 2880 v5.2 Software |
Guidant Corporation St. Paul, MN 55112 |
Approval for the Vigor Model 2880 v5.2 Software. |
P950002/S009 4/3/01 Special |
BAK Interbody Fusion System |
Sulzer Spine-Tech Minneapolis, MN 55439 |
Approval for a change to the labeling of the BAK Interbody Fusion System adding a precaution statement (i.e., The BAK/Proximity device is to be used only in conjunction with a standard BAK device. The safety and effectiveness of the BAK/Proximity device has not been established when used otherwise.) effective April 1, 2001. |
P950032/S022 4/26/01 180-Day |
Apligraf (Graftskin) |
Organogenesis, Inc. Canton, MA 02021 |
Approval for replacement of the soybean trypsin inhibitor reagent in Apligraf manufacture with the newly defined trypsin quenching medium. |
P960004/S018 4/6/01 Real-Time |
ThinLine II/ FINELINE II and ThinLine II/ FINELINE II Sterox Active-Fixation Endocardial Pacing Leads |
Guidant Corporation St. Paul, MN 55112 |
Approval for the use of mannitol as an alternate material to cover the helix on the above referenced active fixation pacing leads. These devices are indicated for permanent pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator. |
P960028/S006 4/25/01 180-Day |
ARRAY® Multifocal UV-Absorbing Silicone Posterior Chamber Intraocular Lens (IOL) – Models SA40N2 and SA40e |
Allergan, Inc. Irvine, CA 92612 |
Approval for the SA40N2 and SA40e lens models. |
P960040/S021 4/5/01 Real-Time |
VENTAK® PRIZM Model 2844 Software Application, Version 3.3 |
Guidant Corporation St. Paul, MN 55112 |
Approval for VENTAK® PRIZM Model 2844 Software Application, Version 3.3. |
P960052/S002 4/4/01 Special |
DERMABOND® Topical Skin Adhesive (2-octyl cyanoacrylate) |
Closure Medical Corporation Raleigh, NC 27616 |
Approval to modify the labeling in order to clarify the instructions for preparing and storing the device. |
D970012/S005 4/25/01 180-Day |
AMS 700 Series Product Line Inflatable Penile Prostheses with InhibiZone Antibiotic Surface Treatment |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for the addition of an antibiotic surface treatment to the CX, CX Preconnect, CXM, and Ultrex models of the AMS 700 Series Product Line Inflatable Penile Prostheses. The modified device will be sold under the tradename AMS 700 Series Product Line Inflatable Penile Prostheses with InhibiZone Antibiotic Surface Treatment. |
P970013/S001 4/30/01 180-Day |
Microny II SR+ Model 2525T and Microny K SR Model 2535K Pulse Generators |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Microny II SR+ Model 2525T and Microny K SR Model 2535K Pulse Generators. |
P970035/S022 4/4/01 180-Day |
S7 with Discrete Technology Over-the-Wire and Rapid Exchange Coronary Stent Systems |
Medtronic AVE, Inc. Santa Rosa, CA 95403 |
Approval for the S7 with Discrete Technology Over-the-Wire (OTW) and Rapid Exchange (RX) Coronary Stent Systems. The devices are indicated for improving coronary luminal diameter in patientss with symptomatic ischemic heart disease due to de novo lesions (length £ 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm and 4.0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present. The RX delivery system will allow for perfusion at an average rate of 2 cc/minute at nominal pressure during the 15-30 second stent deployment procedure only. The rapid exchange stent delivery system is not intended for use as a stand alone PTCA perfusion catheter. |
P980040/S001 4/18/01 180-Day |
SENSAR® Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens (IOL) |
Allergan, Inc. Irvine, CA 92623 |
Approval for the acrylic sheet casting and button fabrication manufacturing processes to be performed at A.M.O. Puerto Rico, Inc., Anasco, Puerto Rico. |
4/6/01 Panel Track |
Medtronic® Model 7250 Jewel® AF Implantable Cardioverter Defibrillator System Medtronic Model 9465 InCheck Patient Assistant and Medtronic Transvene® CS/SVC Model 6937 A Lead |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for the Medtronic® Model 7250 Jewel® AF Implantable Cardioverter Defibrillator System, Medtronic Model 9465 InCheck Patient Assistant and the Medtronic Transvene® CA/SVC Model 6937A Lead. The system is intended to provide pacing, cardioversion and defibrillation for treatment of patients with symptomatic drug refractory atrial fibrillation and/or life-threatening ventricular tachyarrhythmias. |
P980053/S003 4/2/01 180-Day |
Durasphere® Injectable Bulking Agent |
Carbon Medical Technologies, Inc. St. Paul, MN 55110 |
Approval to revise the labeling’s Directions for Use to add instructions for injection of Durasphere® via a periurethral route. |
P990009/S006 4/30/01 Real-Time |
FloSeal® Matrix and Proceed Hemostatic Sealants |
Fusion Medical Technologies, Inc. Freemont, CA 94555 |
Approval for the addition of language to the Package Insert regarding the use of FloSeal® Matrix and Proceed Hemostatic Sealants as agents for nasal/sinus bleeding. |
P990009/S007 4/10/01 Real-Time |
FloSeal Matrix (AKA Proceed) Hemostatic Sealant |
Fusion Medical Technologies, Inc. Fremont, CA 94555 |
Approval for the removal of the neurosurgical exclusion from the "Indications for Use" for FloSeal Matrix® Hemostatic Sealant. |
P990028/S001 4/20/01 180-Day |
FocalSeal-L Synthetic Absorbable Sealant |
Focal, Inc. Lexington, MA 02421 |
Approval for the Post Approval Study Protocol PMS-0001-0. |
P990052/S003 4/2/01 180-Day |
Vibrant® D Soundbridge System (Audio Processor Models 304 and 404) |
Symphonix Devices, Inc. San Jose, CA 95131 |
Approval to change the hinge boss and to change the negative battery contact. |
P990066/S003 4/24/01 180-Day |
Senographe 2000D Full Field Digital Mammography System |
General Electric Medical Systems Milwaukee, WI 53201 |
Approval for revised acquisition workstation (AWS) monitor specifications. |
P990074/S005 4/9/01 180-Day |
McGhan Saline-Filled Breast Implants, Style 363LF |
McGhan Medical Corporation Santa Barbara, CA 93111 |
Approval for a new series of sizes for the Style 363 saline-filled breast implant. The device, as modified, will be marketed under the trade name McGhan Saline-Filled Breast Implants, Style 363LF and is indicated for: 1) breast augmentation for women 18 years or older and 2) breast reconstruction. |
P000014/S004 4/19/01 180-Day |
Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators |
Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626
|
Approval for shipping containers, when used as stated, to maintain a temperature within the range of 2 to 20° C. |
P000018/S003 4/24/01 180-Day |
Novoste Beta-Cath System |
Novoste Corporation Norcross, GA 30093 |
Approval for the post-approval sutdy protocol for the Beta-Cath System. The post-approval study is intended to verify that the corrective actions, intended to help minimize the incidence of device failures and malfunctions seen during the premarket clinical investigation, are successful in reducing the device failure and malfunction rate. |
30-DAY NOTICES (135 Day Supplement Was Not Required) |
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APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P810046/S206 4/13/01 |
OpenSail Coronary Dilatation Catheter |
Guidant Corporation Temecula, CA 92591 |
Change to modify the sidearm assembly and inspection process. |
P860019/S170 4/5/01 |
Maverick Monorial PTCA Catheters |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Changes in the manufacturing process for the Maverick Monorail product line to include the use of a non-tapered production mandrel with blunt ends, and additional preventive measures to ensure that a thin wall condition does not occur in the inflation lumen, including the addition of a 100% Vacuum Decay Test for both the Maverick Monorail and Over-the-Wire PTCA Catheters. |
P900056/S061 4/13/01 |
Rotablator Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052 |
Change in the vendor for water for injection (WFI) which is a component of the RotaGlide Lubricant and is used in the Rotablator System. Fresenius Kabi will produce WFI at their facility in accordance with USP specifications. |
P920047/S014 4/24/01 |
EPT-1000 Cardiac Ablation System |
Boston Scientific San Jose, CA 95134 |
Changes in the manufacturing operation: a change in the welding process from a manual to an automated process, a change in the grit blast media, and removal of a chemical to the weld joint. |
P980001/S030 4/10/01 |
NIROYAL® Elite Over-the-Wire Stent System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Modification to the acceptance criteria for the gel lump size to the SOX component from 0.005" to £ 0.010". |
P980001/S031 4/10/01 |
NIROYAL® Elite Over-the-Wire Stent System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Change in the manufacturing process by using scrapped material in the final functional testing for the SOX component to minimize the amount of destroyed product at final testing. |
P000014/S003 4/19/01 |
Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators |
Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Change to the type of dispenser used to dispense the coating solution and wash buffers during the manufacturing of the coated microwells, a component of the product. |
Summary of PMA Originals & Supplements Approved
Originals: 6
Supplements: 34
Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 36
Total On Hold: 43
Number Greater Than 180 Days: 0
Summary of PMA Supplements Under Review
Total Under Review: 263
Total Active: 152
Total On Hold: 111
Number Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Originals: 7
Supplements: 67
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 34
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 117.9
FDA Time: 81.4 Days MFR Time: 36.5 Days
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