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PMA Final Decisions Rendered for December 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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12/21/00 |
Microny™ SR+ Model 2425T |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Microny™ SR+ Model 2425T single chamber rate adaptive pulse generator, which is programmed with the APS II Programmer with Model 3204a software, the APSm Programmer, and the Model 3500/3510 Programmer with Model 3304 software. The device is indicated for the following: 1) Accepted Patient Conditions warranting chronic cardiac pacing which include: sick sinus syndrome; chronic, symptomatic second- and third-degree AV block; recurrent Adams-Stokes syndrome; and symptomatic bilateral bundle branch block when tachy-arrhythmia and other causes have been ruled out. 2) Atrial Pacing in patients with sinus node dysfunction and normal AV and intraventricular conduction systems. 3) Ventricular Pacing in patients with significant bradycardia and: normal sinus rhythm with only rare episodes of AV block or sinus arrest requiring short periods of pacing support, chronic atrial fibrillation, and severe physical disability. 4) Rate-Modulated Pacing in patients who would benefit from increased pacing rates concurrent with physical activity. |
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12/21/00 |
Q-103 Needle Management Systems |
QCare International, LLC. Marietta, GA 30067 |
Approval for the Qcare Needle Management System. The device is a needle destruction device intended to be used in a home care environment to sever ˝ inch hypodermic needles (gauges 28-29) from insulin syringes and store them for disposal. |
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12/12/00 |
Elecsys® Free PSA Immunoassay for Elecsys 1010 and 2010 immunoassay analyzers, Elecsys® Free PSA CalSet, Elecsys® Free PSA CalCheck |
Roche Diagnostics Corporation Indianapolis, IN 46250 |
Approval for the Elecsys® Free PSA Immunoassay for Elecsys 1010 and 2010 immunoassay analyzers. The device is indicated for: the in vitro quantitative determination of free prostate-specific antigen in human serum and plasma. The Elecsys Free PSA Immunoassay is indicated for measurement of fPSA in conjunction with the Elecsys total PSA assay to develop a ratio (% fPSA) of fPSA to tPSA. This ratio is useful when used in conjunction with the Elecsys total PSA test as an aid in distinguishing prostate cancer from benign prostatic conditions in men age 50 years or older who have a digital rectal examination (DRE) that is not suspicious for prostate cancer and an Elecsys total PSA value in the range 4 ng/ml to 10 ng/ml. Prostate biopsy is required for the diagnosis of prostate cancer. The electrochemilumin-escence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010 and 2010 immunoassay analyzers. |
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PMA/PDP SUPPLEMENTAL APPROVALS |
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APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
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N17004/S013 12/15/00 Real-Time |
Surgical Simplex® P Bone Cement |
Stryker Howmedica Osteonics Corporation Allendale, NJ 07401 |
Approval for removal of the redundant chemical name located directly below the brand name. |
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P840062/S007 12/7/00 180-Day |
Helicote Absorbable Collagen Wound Dressings for Dental Surgery |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for an additional trade name for CollaCote, CollaTape and CollaPlug. These devices will be known as Helicote Absorbable Collagen Wound Dressings for Dental Surgery. The sizes of the wound dressings will be identical to the three CollaCote products. There will be no changes in the device except the use of an additional new trade name. |
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P840068/S040 12/13/00 180-Day |
DELTA®/VISTA® Model 2881 Version 2.0 Software |
Guidant Corporation St. Paul, MN 55112 |
Approval for the VENTAK® AV DDD/ AV II DDD Model 2833 Version 4.0 Software, the VENTAK® VR Model 2841 Version 4.0 Software and the DELTA®/ VISTA® Model 2881 Version 2.0 Software. |
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P880086/S081 12/12/00 Real-Time |
Integrity m DR Model 5336 and SR Model 5136 Pulse Generators |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for pulse generator models Integrity m DR Model 5336 and SR Model 5136 pulse generators. |
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P900061/S039 12/11/00 180-Day |
Medtronic Implantable Cardioverter Defibrillators (Models 7221, 7223, 7227, 7229, 7271 and 7273 |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for labeling changes of the Medtronic Models 7221, 7223, 7227, 7229, 7271 and 7273. |
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P910018/S005 12/6/00 180-Day |
Liposorber® LA-15 System |
Kaneka Pharma America Corporation New York, NY 10022 |
Approval for 1) replacing the sterilization date with the actual expiration date, expressed as month and year, for the following Liposorber® LA-15 System components: a) Liposorber® LA-15 column; b) Sulflux® FS-05 Plasma Separator; and c) tubing system for Plasmapheresis LT-MA2; 2) replacing the slip-type male tubing connectors with Luer-lock type connectors on the separator end-caps of the Sulflux FS-05 Plasma Separator; 3) making the following changes to the tubing system for the Plasmapheresis LT-MA2: a) providing sterile transducer protective filters (found substantially equivalent under 510(k) K983076) in packages of ten; b) reducing the number of connection tubes from ten to eight, adding pinch clips and reducing the sharpness of the plastic spike on each end of the connection tube; c) replacing the stainless steel needles, used to connect each infusion line to a bag or bottle of saline or regeneration fluid, with plastic spikes; d) adding a luer-lock "male" and "female" connector to the end of the waste lines; e) increasing the length of the tubing section between the blood pump and Chamber Level 1 from 80 mm to 90 mm and the length of the tubing section between the waste drip chamber and a "T" connector on the waste line from 35 mm to 50 mm; and, f) adding an infusion line. |
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P910077/S035 12/6/00 Real-Time |
VENTAK® MINI™ IV Automatic Implantable Cardioverter Defibrillator (AICD™) Models 1790 and 1793 |
Guidant Corporation St. Paul, MN 55112 |
Approval for the modification of the MINI™ IV AICD™ header and removing the sterile mineral oil and hex wrench from the package. |
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P920015/S017 12/15/00 180-Day |
Medtronic® Sprint™ Quattro™ Model 6944 Lead |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Medtronic® Sprint™ Quattro™ Model 6944 Lead, which is intended for single long-term use in the right ventricle. This lead has application for patients in which implantable cardioverter defibrillators are indicated. |
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12/22/00 Panel-Track |
ACS:180 and Advia Centaur PSA Assays |
Bayer Corporation Medfield, MA 02052 |
Approval for the ACS:180 and ADVIA Centaur PSA Immunoassay and is indicated for the following: The Bayer ACS:180™ and ADVIA Centaur™ PSA Assays are in vitro devices intended for the quantitative measurement of prostate-specific antigen (PSA) in human serum. These devices are indicated for the measurement of serum PSA in conjunction with digital rectal exam (DRE) as an aid in the detection prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. These devices are further indicated as an aid in the management (monitoring) of prostate cancer patients. |
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P950034/S017 12/20/00 Real-Time |
Seprafilm® Bioresorbable Membrane |
Genzyme Corporation Cambridge, MA 02139 |
Approval for a new size of Seprafilm® and to change the name of the product from Seprafilm® Bioresorbable membrane to Seprafilm® Adhesion Barrier. The labeling has been modified to reflect the new name and new size and the package insert was modified to be included with both sizes. Furthermore, the labeling has been modified to omit the reference to the clinical study in the foreign body precaution. |
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P960013/S009 12/7/00 Real-Time |
Tendril SDX Model 1488T Lead |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the following modifications to the suture sleeves used with the pacemaker leads: the incorporation of titanium dioxide into the suture sleeve material to make the material "more visible during implant"; increasing the inner diameter of the sleeve and; removal of the sleeve eyelet’s. |
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P960016/S005 12/1/00 180-Day |
Livewire TC™ Cardiac Ablation System (Models 402229, 402230, 402231, 402232, 402233, 402235, and 402236) |
St. Jude Medical Minnetonka, MN 55245 |
Approval for eight new 4 mm tip electrode catheters with thermistor only temperature sensing. The catheters, as modified, will be marketed under the trade name Livewire TC™ Cardiac Ablation System. The system is indicated for: interruption of accessory atrioventricular (AV) nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with difficult to control ventricular response to an atrial arrhythmia. |
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P960016/S006 12/1/00 180-Day |
Livewire TC™ Cardiac Ablation System (Models 402205, 402206, 402207, 402208, 402209, 402210, 402211, 402212, 402213, 402214, 402215, and 402216) |
St. Jude Medical Minnetonka, MN 55345 |
Approval for twelve new catheters with a 5 mm tip electrode. The catheters, as modified, will be marketed under the trade name Livewire TC™ XLS™ Cardiac Ablation System. The system is indicated for: interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with difficult to control ventricular response to an atrial arrhythmia. |
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P960030/S008 12/7/00 Real-Time |
Passive Plus DX Models 1346T and 1342T, and Tendril DX Model 1388T Leads |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the following modifications to the suture sleeves used with the pacemaker leads: the incorporation of titanium dioxide into the suture sleeve material to make the material "more visible during implant"; increasing the inner diameter of the sleeve and; removal of the sleeve eyelet’s. |
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P960040/S017 12/13/00 180-Day |
VENTAK® AV DDD/ AV II DDD Model 2833 Version 4.0 Software VENTAK® VR Model 2841 Version 4.0 Software |
Guidant Corporation St. Paul, MN 55112 |
Approval for the VENTAK® AV DDD/ AV II DDD Model 2833 Version 4.0 Software, the VENTAK® VR Model 2841 Version 4.0 Software and the DELTA®/ VISTA® Model 2881 Version 2.0 Software. |
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D970012/S006 12/11/00 |
AMS 700 Series Product Line Inflatable Penile Prostheses |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for the addition of a Parylene-N coating to the inner and outer tubes of the cylinders for all inflatable penile prosthesis models of the AMS 700 Series Product Line. |
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P970015/S017 12/13/00 180-Day |
INTER FIX™ RP Threaded Fusion Device (also known as the INTER FIX™ RP Threaded Fusion Device – Reduced Profile) |
Sofamor Danek USA Memphis, TN 38132 |
Approval for the INTER FIX™ RP Threaded Fusion Device to be also known as the INTGER FIX™ RP Threaded Fusion Device – Reduced Profile. The device will now be marketed under both trade names and will remain indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. The device is to be implanted via an open anterior approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. |
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P970029/S005 12/8/00 Special |
Eclipse TMR Holmium Laser System |
Eclipse Surgical Technologies, Inc. Sunnyvale, CA 94089 |
Approval for two specific additional quality control inspection steps during the manufacturing of the SoloGrip handpiece and the addition of specific language in three places to the Instructions for Use for the SoloGrip handpiece. |
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P980016/S008 12/11/00 180-Day |
Medtronic Implantable Cardioverter Defibrillators (Models 7221, 7223, 7227, 7229, 7271 and 7273) |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for labeling changes of the Medtronic Models 7221, 7223, 7227, 7229, 7271 and 7273. |
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P980016/S015 12/12/00 Real-Time |
Medtronic GEM III VR Model 7231 ICD and Medtronic Model 9971 (GEM III VR) Programmer Application Software |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for Medtronic GEM III VR Model 7231 ICD and Medtronic Model 9971 (GEM III VR) Programmer Application Software. The device, as modified, is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia. |
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P980049/S003 12/14/00 Real-Time |
Alto DR Model 614 ICD and Model 61x (Version 1.04) Programmer Application Software |
ELA Medical Plymouth, MN 55441 |
Approval for Alto DR Model 614 ICD and Model 61x (Version 1.04) Programmer Application Software. |
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P990002/S001 12/28/00 Special |
FemSoft® Insert |
Rochester Medical Corporation Stewartville, MN 55976 |
Approval to add the precaution "avoid heat" to the labeling. The device, as modified, will be marketed under the trade name FemSoft® Insert and is indicated for the management of stress urinary incontinence in adult females. |
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P990009/S002 12/12/00 180-Day |
FloSeal Matrix (AKA Proceed) Hemostatic Sealant |
Fusion Medical Technologies, Inc. Fremont, CA 94555 |
Approval for a labeling change. |
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P990017/S013 12/28/00 Special |
Ancure Endograft System |
Guidant Corporation Menlo Park, CA 94025 |
Apporoval for the addition of a warning in the Instructions for Use. |
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P990027/S001 12/22/00 180-Day |
Technolas 217A Excimer Laser System |
Bausch & Lomb Surgical, Inc. Irvine, CA 92618 |
Approval for a manufacturing site located at Technolas GmbH, Kircheim/Heimstetten, Germany. |
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P990074/S001 12/6/00 180-Day |
Saline Filled Breast Implant |
McGhan Medical Corporation Santa Barbara, CA 93111 |
Approval for a manufacturing site located at McGhan Medico, S.A., Barreal de Heredia, Cost Rica. |
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P990074/S002 12/21/00 180-Day |
Saline-Filled Breast Implant |
McGhan Medical Corporation Santa Barbara, CA 93111 |
Approval for the protocols for the conditions of approval. |
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P990075/S002 12/22/00 180-Day |
Saline-Filled Mammary Prosthesis and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis |
Mentor Corporation Santa Barbara, CA 93111 |
Approval for an increased shell thickness of the Contour Tall Profile styles 5000, 5000PT, 6000, and 6000PT. |
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P990078/S001 12/11/00 Real-Time |
Sunrise HYPERION™ LTK System |
Sunrise Technologies, Inc. Fremont, CA 94538 |
Approval for a change in the Warning section of the labeling. |
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P000018/S001 12/13/00 Special |
Novoste™ Beta-Cath™ System |
Novoste Corporation Norcross, CA 30093 |
Approval for the addition of a precaution to the isotope identification label. |
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P000018/S002 12/18/00 Special |
Novoste™ Beta-Cath™ System |
Novoste Corporation Norcross, GA 30093 |
Approval for the addition of a new quality control test method during the manufacturing process of the b -Cath™ Delivery Catheter. |
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P000022/S001 12/14/00 Real-Time |
BeStent™ 2 with Discrete Technology™ Rapid Exchange Coronary Stent Delivery System |
Medtronic AVE, Inc. Santa Rosa, CA 95403 |
Approval for a change in the labeling to the Bestent™ 2 with Discrete Technology™ Rapid Exchange (RX) Coronary Stent Delivery System. The device is now indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length £ 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm to 4.0 mm. Long term outcome for this implant is unknown at present. The rapid exchange delivery system will allow for perfusion at an average rate of 2cc/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. |
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P830045/S074 12/12/00 Real-Time |
Integrity µ DR Model 5336 and SR Model 5136 Pulse Generators | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for pulse generator models Integrity µ DR Model 5336 and SR Model 5136 pulse generators. |
| 30-DAY NOTICES (135 Day Supplement Was Not Required) | |||
| APPLICATION NUMBER & LTR DATE | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | COMMENTS |
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P840001/S049 12/13/00 |
Model 7499 Extension for the Itrel Spinal Cord Stimulation System |
Medtronic, Inc. Minneapolis, MN 55421 |
Manufacturing process change from a resistance weld to a laser weld. |
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P860019/S166 12/8/00 |
Maxxum PTCA Catheter |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Alternate manufacturing method for tapering the distal end of the catheter tip by a grinding method. |
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P900056/S057 12/5/00 |
Rotablator Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052 |
Alternate vendor for the brake cylinder used in the manufacture of the Rotablator RotaLink Advancer |
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P900056/S058 12/12/00 |
Rotablator Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052 |
Change to the manufacturing process for the Rotablator RotaLink Exchangeable cateter to increase the maximum allowed energy used during the laser weld process on the catheter drive assembly handshake. |
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P900056/S059 12/29/00 |
Rotablator Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052 |
Change to the manufacturing process for the Rotablator RotaLink advancer. The change will increase the pressure with which the front plug is pressed into the turbine housing. |
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P950032/S021 12/21/00 |
Apligraf® (Graftskin) |
Organogenesis, Inc. Canton, MA 02021 |
Change in the relative humidity of the Lunaire incubators used in the Apligraf® manufacturing process. The change will decrease the risk of bacterial contamination due to waterborne organisms during the manufacturing process. |
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P960009/S015 12/13/00 |
Model 7482 Extension for the Activa Deep Brain Stimulation (DBS) System |
Medtronic, Inc. Minneapolis, MN 55421 |
Manufacturing process change from a resistance weld to a laser weld. |
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P960043/S028 12/12/00 |
The Closer™ and the Closer S™ 6 French Suture Mediated Closure Devices |
Perclose Redwood City, CA 94063 |
Reducing the sheath to guide tensile strength acceptance criteria to a minimum of 5 lbf. from 7 lbf. |
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P970020/S026 12/5/00 |
TETRA™ Coronary Stent System |
Guidant Corporation Temecula, CA 92591 |
Change in the instructions to the stent crimp operator for acceptable twist of the balloon folds. |
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P970035/S023 12/19/00 |
S670, S660 and BeStent™2 with Discrete Technology™ Rapid Exchange Coronary Stent System |
Medtronic AVE, Inc. Santa Rosa, CA 95403 |
Manufacturing bonding process change for conversion bonds and jacket bonds. |
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P980001/S027 12/27/00 |
NIR™ Premounted Stent Delivery System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Elimination of the creep test for assessing package seal integrity. |
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P990074/S003 12/15/00 |
Saline Filled Breast Implant |
McGhan Medical Corporation Santa Barbara, CA 93111 |
Change in the product LAL testing from a release test for every sterilization lot, to a manufacturing change control tool used for process and material changes. There will be no adverse effect to the device as a result of changing the LAL testing from a release test to a qualification test. Historical records of LAL testing on finished products demonstrate the product manufacturing process is controlled and predictable, delivering an endotoxin-free product. |
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P000022/S003 12/19/00 |
S670, S660 and BeStent™2 with Discrete Technology™ Rapid Exchange Coronary Stent System |
Medtronic AVE, Inc. Santa Rosa, CA 95403 |
Manufacturing bonding process change for conversion bonds and jacket bonds. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 31
Summary of PMA Originals Under Review
Total Under Review: 77
Total Active: 39
Total On Hold: 38
Number Greater Than 180 Days: 0
Summary of PMA Supplements Under Review
Total Under Review: 217
Total Active: 142
Total On Hold: 75
Number Greater Than 180 Days: 1
Summary of All PMA Submissions Received
Originals: 8
Supplements: 55
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 31
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time) 98.3
FDA Time: 77.5 Days MFR Time: 20.8 Day
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