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PMA Final Decisions Rendered for February 2004 |
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PMA Original Approvals
2/5/04 |
Abbott AxSym Antibody to HCV |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the Abbott AxSYM Antibody to HCV. The device is indicated for the qualitative detection of anti-HCV recombinant proteins in human serum or plasma (potassium EDTA, sodium EDTA, sodium heparin, lithium heparin, sodium citrate, and potassium oxalate). |
2/5/04 |
AxSYM® Free PSA |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the AxSYM® Free PSA Assay. The device is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of free prostate specific antigen (PSA) in human serum. The AxSYM Free PSA assay is intended to be used in PSA values between 4 and 10 ng/ml and non-suspicious DRE to determine the % Free PSA Value. The AxSYM% Free PSA value can be used as an aid in discriminating between prostate cancer and benign disease. |
2/19/04 |
Prolieve™ Thermodilatation System |
Celsion Corporation Columbia, MD 21046 |
Approval the Prolieve™ Thermodilatation System, which is a transurethral microwave therapy device that provides a non-surgical, minimally invasive procedure for the treatment of symptomatic BHP in men with a prostate size of 20 to 80 grams, a prostatic urethra length of 1.2 to 5.5 cm and in whom drug therapy (e.g., Proscar®) in typically indicated. |
2/4/04 |
ORTHOVISC® High Molecular Weight Hyaluronan |
Anika Therapeutics, Inc. Woburn, MA 01801 |
Approval for the ORTHOVISC® High Molecular Weight Hyaluronan. The device is indicated fo the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen). |
2/12/04 |
DakoCytomation EGFR pharmDx™ |
DakoCytomation California, Inc. Carpinteria, CA 93013 |
Approval for the DakoCytomation EGFR pharmDx. The device is indicated for: the EGFR pharmDX assay is a qualitative immunohistochemical (IHC) kit system to identify epidermal growth factor receptor (EGFR) expression in normal and neoplastic tissues routinely-fixed for histological evaluation. EGFR pharmDx specifically detects the EGFR (HER1) protein in EGFR-expressing cells. EGFR pharmDx is indicated as an aid in identifying colorectal cancer patients eligible for treatment with ERBITUX (cetuximab). |
PMA Supplemental Approvals
N18033/S039 2/4/04 Real-Time |
ACUVUE® COLOURS™ Brand (etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker |
VISTAKON, Division of Johnson and Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Approval for an alternative binding polymer to the ACUVUE 2 COLOURS Brand (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker. |
P780012/S009 2/2/04 180-Day |
Abbott Axsym HAVAB® 2.0 |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the Abbott Axsym HAVAB® 2.0. The device, as modified, will be marketed under the trade name Axsym HAVAB® 2.0 and is indicated for the qualitative detection of total antibody to hepatitis A virus (anti-HAV) in human serum or plasma. A test for anti-HAV is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination. |
P790019/S011 2/2/04 180-Day |
Abbott AxSYM HAVAB-M® 2.0 |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the Abbott AxSYM HAVAB-M® 2.0. The device, as modified, will be marketed under the trade name AxSYM HAVAB-M® 2.0 and is indicated for the qualitative detection if IgM antibody to hepatitis A virus (IgM anti-HAV) in human serum or plasma. A test for IgM anti-HAV is indicated as an aid in the diagnosis of acute or recent hepatitis A viral infection. |
P820060/S013 2/2/04 180-Day |
Abbott Architect AFP |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the addition of the AFP assay on the Architect immunoassay instrument. The device, as modified, will be marketed under the trade name Architect AFP assay and is indicated for the quantitative determination of alpha-fetoprotein (AFP) in : 1) Human serum or plasma to aid in the management of patients with nonseminomatosus testicular cancer. 2) Human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of fetal open neural tube defects (NTD). |
P820060/S016 2/2/04 180-Day |
Abbott Architect AFP for the Architect i2000sr analyzer |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the use of the Abbott Architect AFP assay on the Architect i2000sr analyzer. The device, as modified, will be marketed under the trade name Abbott Architect AFP assay for the Architect i2000 analyzer and is indicated for the following: 1) Human serum or plasma to aid in the management of patients with nonseminomatosus testicular cancer. 2) Human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of open neural tube defects (NTD). Test results when used in conjunction with ultrasonography or amniography are a safe and effective aid in the detection of fetal open NTD. |
P820060/S019 2/2/04 Real-Time |
Abbott AxSYM AFP |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for a change in protocol for the automated dilution protocol in Abbott AxSYM software version 3.60 and version 4.01. |
P830055/S085 2/25/04 180-Day |
LCS Total Knee System |
Depuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for a manufacturing facility for the trochlear components of the patellofemoral replacement system, in Vandalia, Ohio. |
P890019/S009 2/20/04 Special |
DiaSorin ETI-AB-HAVK PLUS Assay |
DiaSorin, Inc. Stillwater, MN 55082 |
Approval for the following changes to the package insert: The supplement contains a revision in the assay package insert that states “All lots of incubation buffer are interchangeable between ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS.” |
P910007/S005 2/2/04 180-Day |
Abbott AxSYM Total PSA |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the Abbott AxSYM Total PSA assay. The AxSY Total PSA assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of total PSA (both free PSA and PSA complexed to alpha-1 antichymotrypsin) in human serum: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) as an adjunctive test to aid in the management of prostate cancer patients. |
P910007/S007 2/2/04 180-Day |
Architect Total PSA assay |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the Abbott Architect Total PSA assay. The Architect Total PSA assay is indicated: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) as an adjunctive test to aid in the management of prostate cancer patients. |
P910007/S009 2/2/04 180-Day |
Abbott IMx Total PSA assay |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the Abbott IMx Total PSA assay. The device, as modified, will be marketed under the trade name Abbott IMx Total PSA assay and is indicated as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men aged 50 years or older. Prostatic biopsy is required for the diagnosis of cancer. |
P910077/S041 2/6/04 180-Day |
VENTAK AV, PRIZM, VITALITY, VITALITY AVT Implantable Cardioverter Defibrillators |
Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the Indications for Use and Clinical Study section labeling. The devices are indicated for: For ICDs (VENTAK PRx, MINI, VITALITY, VENTAK AV and PRIZM): Guidant ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. For VITALITY AVT: Guidant VITALITY AVT is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. This device is also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias. For CRT-Ds (CONTAK CD and RENEWAL): Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. Guidant CRT-Ds are also indicated for reduction of symptoms of moderate to severe heart failure (NYHA III/IV) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF≤ 35%) and QRS duration ≥ 120 ms. |
P930029/S021 2/5/04 Real-Time |
Medtronic RF Enhancr® II Family of Ablation Catheters |
Medtronic EP Systems Minneapolis, MN 55432 |
Approval for a line extension to the commercially available RF Enhancr® catheter line with the changes limited to a new handle design and associated packaging changes. The device, as modified, will be marketed under the trade name Medtronic RF Enhancr® II family of Ablation Catheters and is indicated for use with the Medtronic RF Power generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia. |
P930039/S017 2/9/04 Real-Time |
Medtronic CapSureFix Novus Model 4076 Lead |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for modifications to the Model 4076 lead. |
P950029/S019 2/13/04 Real-Time |
Symphony/ELA Rhapsody ROM Mask T3 (Version GXD T3) |
ELA Medical, Inc. Plymouth, MN 55441 |
Approval for the firmware modifications (Version GXD T3) of the Symphony and ELA Rhapsody pacemakers. |
P950039/S011 2/9/04 180-Day |
Thinprep 2000 System |
Cytyc Corporation Boxborough, MA 01719 |
Approval for an additional manufacturing site for the filter manufacturing process. The site is located at Cytyc New Hampshire, Londonderry, New Hampshire. |
P960040/S036 2/6/04 180-Day |
VENTAK PRx and MINI Implantable Cardioverter Defibrillators |
Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the Indications for Use and Clinical Study section labeling. The devices are indicated for: For ICDs (VENTAK PRx, MINI, VITALITY, VENTAK AV and PRIZM): Guidant ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. For VITALITY AVT: Guidant VITALITY AVT is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. This device is also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias. For CRT-Ds (CONTAK CD and RENEWAL): Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. Guidant CRT-Ds are also indicated for reduction of symptoms of moderate to severe heart failure (NYHA III/IV) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF≤ 35%) and QRS duration ≥ 120 ms. |
P960043/S048 2/11/04 180-Day |
Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) System |
Abbott Vascular Devices Redwood City, CA 94063 |
Approval for a name change, from Perclose® AT Mono-Glide 6 French Suture Mediated Closer (SMC) System to Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) Systems. The device, as modified, will be marketed under the trade name Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) Systems and is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 8 Fr. sheaths. The Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) Systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions. |
P960058/S033 2/18/04 Real-Time |
HiResolution™ Bionic Ear System |
Advanced Bionics Corporation Sylmar, CA 91342 |
Approval for a new Auria (behind-the-ear) accessory, called the Auria™ T-Coil. The accessory provides Auria users an optional interface for telephones and induction loop-based assistive listening system. |
P970043/S016 2/9/04 Real-Time |
LADARVision® 4000 Excimer Laser System |
Alcon Laboratories, Inc. Orlando, FL 32826 |
Approval for a new laser assembly system to replace the existing assembly in the approved LADARVision® 4000 Excimer Laser System. |
P980003/S009 2/5/04 Real-Time |
Chilli® Cooled Ablation Catheters |
Boston Scientific Corporation San Jose, CA 95134 |
Approval for the use of the Chilli catheters with the EPT-1000 XP RF generator using the same maximum output power as that used with the Model 8004 and EPT-1000 TC generators. |
P980006/S005 2/11/04 180-Day |
PureVision™ (balafilcon A) Visibility Tinted Contact Lens |
Bausch & Lomb Rochester, NY 14609 |
Approval to modify the post-approval study for the device. |
P980007/S002 2/5/04 180-Day |
Abbott Architect Free PSA |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the Architect Free PSA assay. |
P980007/S003 2/5/04 180-Day |
Abbott IMx® Free PSA |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for modification of the Abbott Architect Free PSA reagents to be used with the IMx® Free PSA and is indicated for: The IMx® Free PSA assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of free prostate specific antigen (PSA) in human serum. The IMx® Free PSA Assay is intended to be used in conjunction with the IMx® Total PSA assay in men aged 50 years or older with total PSA values between 4 and 10 ng/mL and non-suspicious DRE to determine the % free PSA value. The IMx % free PSA value can be used as an aid in discriminating between prostate cancer and benign disease. |
P980035/S032 2/20/04 180-Day |
EnPulse™ Implantable Pulse Generator Models E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33, E2D01, E2D03, E2VDD01, E2SR01, E2SR03, E2SR06 and Model 9991 Application Software |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the EnPulse™ Implantable Pulse Generator Models E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33, E2D01, E2D03, E2VDD01, E2SR01, E2SR03, E2SR06 with Atrial Capture Management and Model 9991 Application Software. The device, as modified, will be marketed under the trade name EnPulse™ IPG and is indicated as follows: EnPulse™ pacemakers are indicated for use in patients who are experiencing accepted conditions warranting chronic cardiac pacing which include: 1) Symptomatic paroxysmal or permanent second or third-degree AV block 2) Symptomatic bilateral bundle branch block 3) Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders. 4) Bradycardia-tachycardia syndrome 5) Vasovagal syndromes or hypersensititve carotid sinus syndromes. EnPulse™ pacemakers are also indicated for use in patients who may benefit from rate responsive pacing to support cardiac output during varying levels of activity. Using rate response modes may restore heart rate variability by improving cardiac output. These devices are also indicated for use in patients who may benefit from maintenance of AV synchrony through the use of dual chamber modes and atrial tracking modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony. Dual chamber modes are indicated for use in patients who have experienced one or both of the following conditions. 1) Various degrees of AV block 2) VVI intolerance (for example, pacemaker syndrome) in presence of persistent sinus rhythm. The device is also indicated for VDD pacing in patients who have adequate rates and on or both of the following conditions. 1) A requirement for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This includes the presence of complete AV block when atrial contribution is needed for hemodynamic benefit or when pacemaker syndrome had existed or is anticipated. 2) A requirement for intermittent ventricular pacing despite a normal sinus rhythm and normal AV conduction. |
P980035/S033 2/17/04 Real-Time |
Medtronic Sigma Models SS106, SSR306, SC203, SDR203, SD303, SDR303, DR353 and SVDD303 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for minor manufacturing modifications and improvements. |
P990026/S021 2/25/04 180-Day |
GlucoWatch G2 Biographer |
Cygnus, Inc. Redwood City, CA 94063 |
Approval for an expansion of the labeling to include a description of pre-treatment products and a method to minimize the affects of skin irritation without affecting the accuracy of G2 Biographer glucose measurements. |
P990041/S004 2/20/04 Special |
DiaSorin ETI-AB-EBK PLUS Assay |
DiaSorin, Inc. Stillwater, MN 55082 |
Approval for the following changes to the package insert: The supplement contains a revision in the assay package insert that states “All lots of incubation buffer are interchangeable between ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS.” |
P990043/S005 2/12/04 Special |
DiaSorin ETI-EBK PLUS Assay |
DiaSorin, Inc. Stillwater, MN 55082 |
Approval for the following changes to the package insert: The supplement contains a revision in the assay package insert that states “All lots of incubation buffer are interchangeable between ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS.” |
P990054/S005 2/9/04 Real-Time |
Chilli® and Chilli® RPM Cooled Ablation Catheters |
Boston Scientific Corporation San Jose, CA 95134 |
Approval for the use of the Chilli and Chilli RPM catheters with the EPT-1000 XP RF generator using the same maximum output power as that used with the Model 8004 and EPT-1000 TC generators. |
P990066/S016 2/19/04 180-Day |
Senographe 2100D Full Field Digital Mammography System |
GE Medical Systems Milwakee, WI 53188 |
Approval for changes in ergonomics, the image acquisition chain, image presentation on the AWS, and connectivity. In addition the application requested additional image quality claims and QC manual changes for QC test technique factors and procedures under MQSA. The device, as modified, will be marketed under the trade name Senographe 2100D Full Field Digital Mammography System. |
P990071/S004 2/24/04 Real-Time |
Stockert 70 Remote Control accessory and Connection Cable |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for the addition of a Stockert Remote Control and Connection Cable. The device, as modified, will be marketed under the trade name Stockert Remote Control and Connection Cable and is indicated for use in conjunction with the Stockert 70 Radiofrequency Generator to be used in conjunction with a compatible catheter for cardiac ablation procedures. |
P000018/S035 2/17/04 180-Day |
Novoste™ Beta-Cath™ System |
Novoste Corporation Norcross, GA 30093 |
Approval for modifications to the Alpha-series Transfer Devices (Alpha IV, Rev. 2, Alpha V, and Alpha VI), and modifications to the labeling for the Beta-Cath™ 5F and Beta-Cath™ 3.5F Systems. |
P000040/S004 2/24/04 180-Day |
HTA® System |
Boston Scientific Corporation Natick, MA 01760 |
Approval for updated labeling that reflects the 2 and 3 year patient follow-up data. The device, as modified, will be marketed under the trade name HTZ® System and is indicated for ablation of the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete. |
P010012/S017 2/6/04 180-Day |
CONTAK CD and RENEWAL Cardiac Resynchronization Therapy Defibrillators |
Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the Indications for Use and Clinical Study section labeling. The devices are indicated for: For ICDs (VENTAK PRx, MINI, VITALITY, VENTAK AV and PRIZM): Guidant ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. For VITALITY AVT: Guidant VITALITY AVT is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. This device is also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias. For CRT-Ds (CONTAK CD and RENEWAL): Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. Guidant CRT-Ds are also indicated for reduction of symptoms of moderate to severe heart failure (NYHA III/IV) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF≤ 35%) and QRS duration ≥ 120 ms. |
P010012/S022 2/12/04 Special |
EASYTRAK IS-1 Lead, Models 4535, 4536, 4537, 4538; EASYTRAK 1 Lead Models 4510, 4511, 4512, 4513 |
Guidant Corporation St. Paul, MN 55112 |
Approval to modify lead manuals. |
P010013/S006 2/5/04 180-Day |
NovaSure Impedence Controlled Endometrial Ablation System |
Novacept, Inc. Palo Alto, CA 94303 |
Approval for a manufacturing site located at Novacept, Heredia, Costa Rica. |
P010031/S008 2/6/04 180-Day |
InSync® II Protect Model 7295 with Model 9992 Application Software |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Medtronic® InSync® II Protect Model 7295 with Model 9992 Application Software. The device, as modified, will be marketed under the trade name Medtronic® InSync® II Protect Model 7295 with Model 9992 Application Software and is indicated as follows: The InSync ® II Protect provides ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction < 35% and a QRS duration > 130 ms. The InSync II Protect device only allows arrhythmias in the VF zone to receive treatment. Arrhythmias in the Monitor Only zone will not be treated by the device. |
P010065/S002 2/5/04 180-Day |
NeedleZap |
E Med Future, Inc. Columbus, OH 43230 |
Approval for a manufacturing site located at Frantz Medical Development, Ltd., Mentor, Ohio. |
P020004/S005 2/25/04 180-Day |
Gore EXCLUDER™ Bifurcated Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff, AZ 860001 |
Approval for a modified version of the Gore EXCLUDER™ Bifurcated Endoprosthesis. |
P020018/S001 2/2/04 180-Day |
Zenith™ AAA Endovascular Graft and H&L-B One-Shot™ Introduction System |
Cook, Inc. Bloomington, IN 47402 |
Approval for the long-term study of the device. |
P020018/S002 2/12/04 180-Day |
Zenith™ AAA Endovascular Graft and H&L-B One-Shot™ Introduction System |
Cook, Inc. Bloomington, IN 47402 |
Approval to increase the diameter of the suprarenal attachment barb of the Zenith® AAA Endovascular Graft. |
P020023/S001 2/4/04 Real-Time |
Restylane™ Injectable Gel |
Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Approval for increasing the expiration dating from Restylane form 12 months to 24 months. |
P020025/S001 2/23/04 180-Day |
Blazer XP RPM |
Boston Scientific Corporation San Jose, CA 95134 |
Approval for the Blazer XP RPM Catheter which combines the features of the Blazer II XP with the Real Time Position Management (RPM) tracking system technology approved for the Chilli RPM Catheter. |
30-Day Notices (135 Day Supplement was not required)
P830060/S053 2/10/04 |
Ventak |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P910073/S044 2/10/04 |
Endotak/Endurance/Reliance |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P910077/S044 2/10/04 |
Ventak PRx/ Mini III/Mini IV |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P940008/S018 2/10/04 |
RES-Q |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P940031/S030 2/10/04 |
Meridian/Discovery |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P940034/S015 2/10/04 |
Amplified Mycobacterium Tuberculosis Direct Test |
Gen-Probe, Inc. San Diego, CA 92121 |
Change to QC specification for the release of the Amplification Reagent. |
P950001/S010 2/10/04 |
Selute |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P960004/S024 2/10/04 |
Fineline/Thinline |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P960006/S009 2/10/04 |
Sweet Tip Rx/ Sweet Picotip Rx/ Flextend |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P960040/S040 2/10/04 |
Ventak AV/ Prizm/Prizm 2/ Vitality |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
D970003/S027 2/10/04 |
Pulsar Max/ Discovery II/ Insignia |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P980003/S012 2/9/04 |
Chilli II Cooled Ablation Catheter |
Boston Scientific Corporation San Jose, CA 95134 |
Four manufacturing changes: 1) change to cooling lumen extrusion; 2) change to the cleaning process; 3) change in the wrap; and 4) change in the distal ring electrode grooves. |
P990046/S010 2/27/04 |
ATS Open Pivot Bileaflet Heart Valve |
ATS Medical Minneapolis, MN 55447 |
Change in the grinding operation used during manufacturing of orifices. |
P000025/S013 2/25/04 |
MED-EL COMBI 40+ Cochlear Implant System |
MED-EL Corporation Durham, NC 27713 |
Addition of an alternative supplier for the electrode wire used in the MED-EL Combi 40+ Cochlear Implant. |
P000033/S001 2/13/04 |
IntraCoil® Peripheral stent |
ev3 Plymouth, MN 55442 |
Change in the manufacturing process to propose an alternate wire polishing vendor for the nitinol wire polishing process. |
P010012/S021 2/10/04 |
Contak CD/ CD2/Renewal/ Easytrak |
Guidant Corporation St. Paul, MN 55112 |
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
P010033/S007 2/10/04 |
QuantiFERON®-TB |
Cellestis, Inc. Valencia, CA 91355 |
Change to the manufacturing process of the QuantiFERON®-TB to an alternative substrate reagent to increase the shelf life of the kit to 3 years. |
P020023/S002 2/13/04 |
Restylane™ Injectable Gel |
Q-Med AB Upsalla, Sweden S-752 28 |
Two manufacturing changes involving the Restylane production process. |
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 44
Summary of PMA Originals Under Review
Total Under Review: 87
Total Active: 43
Total On Hold: 44
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 198
Total Active: 103
Total On Hold: 95
Number Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Originals: 4
Supplements: 36
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 44
Number of Denials: 0
Average Days Fr Receipt to Decision
(Total Time): 294.5
FDA Time: 102.5 Days MFR Time: 192
Days
Updated March 12, 2004
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