|
PMA Final Decisions Rendered for February 2005 |
 |
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.
None for February 2005. |
P810002/S058 |
SJM Masters Series Aortic Valved Prosthesis with Vascutek Gelweave Valsalva Graft (Model VAVGJ-515) |
St. Jude Medical, Inc. |
Approval for an additional configuration of the aortic valved graft using the SJM Masters Series Aortic Valved Prosthesis with the Vascutek Gelweave Valsalva Graft. The device, as modified, will be marketed under the trade name SJM Masters Series Aortic Valved prosthesis with Vascutek Gelweave Valsalva Graft (model VAVGJ-515) and is indicated for the replacement of a malfunctioning native or prosthetic aortic heart valve and ascending aorta. |
P810055/S071 |
CeeOn PMMA UV-Light Absorbing Posterior Chamber (IOLs) |
Advanced Medical Optics |
Approval to modify the “Indications” statements for all legally marketed IOLs under the above referenced PMAs to reflect adults as opposed to adults older than 60 years of age. |
P840002/S010 |
TapCath and TapScope Disposable Transesophageal Probes |
CardioCommand, Inc. |
Approval for a manufacturing site at CardioCommand, Inc., Tampa, Florida. |
P860004/S065 |
SynchroMed II Infusion System |
Medtronic, Neurological |
Approval for modifications to the 1) Protocol driver for the SynchroMed II application software, 2) SynchroMed II application software, and 3) final Functional Test (FFT) manufacturing software. |
P860004/S066 |
SynchroMed® Implantable Infusion System for the Intrathecal Administration of Prialt® (ziconotide) |
Medtronic, Neurological |
Approval for the Intrathecal Administration of Prialt (ziconotide). The device, as modified, will be marketed under the trade name SynchroMed Implantable Infusion System and is indicated for the chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe, chronic pain. |
P860008/S017 |
TapCath and TapScope Disposable Transesophageal Probes |
CardioCommand, Inc. |
Approval for a manufacturing site at CardioCommand, Inc., Tampa, Florida. |
P860019/S202 |
PTCA Balloon Catheters, Express2™ Coronary Stent System and Taxus Express2™ |
Boston Scientific Corporation |
Approval to add a specification for acceptable pyrogen level to the hypotube component. |
P880070/S011 |
CeeOn Heparin Surface Modified UV-Light Absorbing Anterior Chamber (IOLs) |
Advanced Medical Optics |
Approval to modify the “Indications” statements for all legally marketed IOLs under the above referenced PMAs to reflect adults as opposed to adults older than 60 years of age. |
P880081/S030 |
UV-Absorbing Silicone Posterior Chamber Intraocular Lenses (IOLs) |
Advanced Medical Optics |
Approval to modify the “Indications” statements for all legally marketed IOLs under the above referenced PMAs to reflect adults as opposed to adults older than 60 years of age. |
P890003/S079 |
CareLink Monitor Models 2490G, 2490H and 2490J |
Medtronic, Inc. |
Approval for a manufacturing site located at Plexus Services Corporation, Bothell, Washington. |
P890003/S080 |
Medtronic Model 2090 CareLink Programmer with Telemetry C |
Medtronic, Inc. |
Approval for the addition of distance telemetry functionality to the currently approved programmer. The device, as modified, will be marketed under the trade name Medtronic Model 2090 CareLink Programmer with Telemetry C and is indicated for use in the interrogation and programming of implantable medical devices. |
P890057/S017 |
Model 3100B High Frequency Oscillatory Ventilator |
Bird Products Corporation |
Approval for a manufacturing site located at Bird Products Corporation, Palm Springs, California. |
P900056/S082 |
Rotablator Rotational Angioplasty System |
Boston Scientific Corp. |
Approval for changes to the Directions for Use (DFU) manual for the Rotablator console unit. The changes include removal of the references to the console recorder connection, updates to the contact information and catalog numbers, and other minor clarifications. |
P910077/S046 |
Model 3120 ZOOM? Latitude™ Programmer/Recorder/Monitor, Model 3122 Antenna accessory, Model 3130 Accessory kit, and Software Application Models 2909, 2812, 2833, 2840, 2841, 2843, 2844, 2845, 2848, 2849, 2857, 2865, 2880, 2881, 2890, 2891, 2892 |
Guidant Corporation |
Approval for the Model 3120 ZOOM Latitude Programming System. The Model 3120 PRM is intended to be used as a complete system to communicate with Guidant implantable pulse generators. The software in use controls all communication functions for the pulse generator. For detailed software application instructions, refer to the System Guide for the Guidant pulse generator being interrogated. |
| P920014/S024 2/2/05 180-Day |
Thoratec® HeartMate® XVE and VE Left Ventricular Assist System (LVAS) | Thoratec Corporation Burlington, MA 01803 |
Approval for modifications to the existing System Monitor design, which is used with the HeartMate XVE and VE devices. |
| P920047/S026 2/28/05 Real-Time |
Blazer II and Blazer II XP Cardiac Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Approval for the Blazer II and Blazer II XP catheters with modified steering wire subassemblies. |
| P930016/S019 2/18/05 180-Day |
STAR S4™ Excimer Laser and WaveScan WaveFront® Systems | VISX, Inc. Santa Clara, CA 95051 |
Approval for the addition of an iris identification and registration system and an ozone compensation system to the STAR S4 Excimer Laser and WaveScan WaveFront Systems. The device, as modified, will be marketed under the trade name STAR S4-IE Excimer Laser System. |
| P950014/S023 2/18/05 180-Day |
Prostatron™ | Urologix, Inc. Minneapolis, MN 55447 |
Approval for modification of the Prostatron labeling regarding the treatment of patients 1) with implanted active devices (including pacemakers and defibrillators), 2) in urinary retention, and 3) with median prostatic lobes. |
| P950014/S024 2/23/05 Real-Time |
Prostatron™ | Urologix, Inc. Minneapolis, MN 55447 |
Approval to change location balloon material from latex to silicone, to change the method of attaching the location balloon due to the new material, and to remove the current latex sensitivity caution and other references to latex in the labeling. |
| P960040/S049 2/18/05 Real-Time |
Model 2812 Version 1.3 | Guidant Corporation St. Paul, MN 55112 |
Approval for the application software Model 2812 version 1.3. |
| P970003/S055 2/1/05 Real-Time |
NeuroCybernetic Prosthesis (NCP) System | Cyberonics, Inc. Houston, TX 77058 |
Approval for the Model 250 Programming Software – Version 7.0 for use with Model 100 Versions B and C, Model 101 Versions 1 and 2, and Models 102 and 102R pulse generators. |
| P970008/S024 2/18/05 180-Day |
Targis System | Urologix, Inc. Minneapolis, MN 55447 |
Approval for modification of the Prostatron labeling regarding the treatment of patients 1) with implanted active devices (including pacemakers and defibrillators), 2) in urinary retention, and 3) with median prostatic lobes. |
| P970008/S025 2/15/05 Real-Time |
Urologix Targis™ System for the Treatment of BPH | Urologix, Inc. Minneapolis, MN 55447 |
Approval for the following changes to the device: 1) the change of the insertion tip and adhesive of the Cooled ThermoCath Microwave Delivery System (CTC MDS) to increase to the flexibility of the catheter; 2) the change of the insertion tip and adhesive of the Targis™ Microwave Delivery System to the same catheter type as the CTC MDS; and 3) the addition of Texin 950 UV stabilized tubing for the shaft of the CTC catheter. |
| D970012/S016 2/11/05 180-Day |
AMS 700 Series Product Line Inflatable Penile Prostheses with InhibiZone™ Antibiotic Surface Treatment | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for updating the labeling of the AMS 700 InhibiZone™ treated devices to reflect the amount of antibiotics found on these device, as modified, will be marketed under the trade name AMS 700 Series Product Line Inflatable Penile Prostheses with InhibiZone™ Antibiotic Surface Treatment. |
| P970015/S030 2/4/05 Real-Time |
LT-CAGE™ Lumbar Tapered Fusion Device (Ti and PEEK) | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for the inclusion of additional fusion cage component designs. Specifically, these design changes involved the incorporation of a rounded profile to the closed end of the tapered cage components. The modified tapered cage components can only be implanted via an anterior open surgical approach. |
| P970018/S009 2/11/05 Real-Time |
PrepStain™ System | Tripath Imaging, Inc. Durham, NC 27703 |
Approval for modification to the SurePath™ Slide preparation method which will be marketed under the trade name PrepStain™ System and is indicated for use as a liquid-based thin layer cell preparation process. The PreStain™ System produces SurePath™ slides that are intended as replacements for conventional gynecologic Pap smears. Surepath™ slides are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses. |
| P970058/S020 2/17/05 180-Day |
ImageChecker M5000, ImageChecker M5000 DM, ImageChecker M5000LX, ImageChecker M5000 M5000 DX Version 8.0 | R2 Technology, Inc. Sunnyvale, CA 94087 |
Approval for improvements in the CAD detection algorithm and the introduction of more choice in operating points for both analog and digital images. |
| P980040/S006 2/4/05 Real-Time |
Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber (IOLs) | Advanced Medical Optics Santa Ana, CA 92799 |
Approval to modify the “Indications” statements for all legally marketed IOLs under the above referenced PMAs to reflect adults as opposed to adults older than 60 years of age. |
| P990053/S011 2/25/05 135-Day |
Oxifirst™ Fetal Oxygen Saturation Monitoring System | Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 |
Approval for the qualification of an additional supplier for the two light emitting diodes within the oximetry sensor. |
| P990080/S005 2/4/05 Real-Time |
CeeOn Edge and Tecnis Foldable UV-Light Absorbing Posterior Chamber (IOLs) | Advanced Medical Optics Santa Ana, CA 92799 |
Approval to modify the “Indications” statements for all legally marketed IOLs under the above referenced PMAs to reflect adults as opposed to adults older than 60 years of age. |
| P000058/S015 2/4/05 Real-Time |
InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for the inclusion of additional fusion cage component designs. Specifically, these design changes involved the incorporation of a rounded profile to the closed end of the tapered cage components. The modified tapered cage components can only be implanted via an anterior open surgical approach. |
| P010012/S031 2/9/05 180-Day |
CONTAK RENEWAL 3 RF CRT-D Models H210/H215/H250/H255 and
CONTAK RENEWAL 3 RF HE CRT-D Models H217/H219/H257/H259 and CONSULT Programmer Software Application, Model 2845 Version 4.6 |
Guidant Corporation St. Paul, MN 55112 |
Approval for the addition of wandless telemetry to your currently market-approved CRT-D devices that will allow communication with the programmer at an increased distance. The device, as modified, will be marketed under the trade name CONTAK RENEWAL 3 RF and is indicated for the following: The CONTAK RENEWAL 3 RF CRT-D is indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF = 35%) and QRS duration = 120 ms. |
| P010012/S041 2/11/05 Special |
CONTAK RENEWAL 3, Models H170, H175, H177 and H179 | Guidant Corporation St. Paul MN 55112 |
Approval for labeling changes. |
| P010012/S042 2/2/05 Real-Time |
CONTAK RENEWAL CRT-D Model H125 | Guidant Corporation St. Paul, MN 55112 |
Approval for header assembly changes to the device. The device, as modified, will be marketed under the trade name Contak Renewal CRT-D Model H135. |
| P010021/S005 2/11/04 Special |
VITROS Immunodiagnostic Anti-HCV Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Approval for modification of raw material specification. |
| P010025/S005 2/18/05 180-Day |
Selenia Full Field Digital Mammography System | Lorad Danbury, CT 06810 |
Approval for addition of automatic exposure (AEC) system, and related changes in Operator’s Manual and QC test and QC manual under MQSA. |
| P010030/S006 2/15/05 Real-Time |
LifeVest™ (WCD® 300) Device with Application Software Version 4.0 | Lifecor, Inc. Pittsburgh, PA 15231 |
Approval for minor changes in software, hardware and associated labeling. |
| P020009/S019 2/15/05 Special |
Express, Express2™ Coronary Stent System (Monorail and Over-the-Wire) |
Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for labeling changes that strengthen the instructions regarding appropriate methods to be used when a physician experiences withdrawal resistance following stent deployment and balloon deflation. |
| P020009/S020 2/15/05 Special |
PTCA Balloon Catheters, Express2 Coronary Stent System and Taxus Express2 | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval to add a specification for acceptable pyrogen level to the hypotube component. |
| P020025/S010 2/28/05 Real-Time |
Blazer II and Blazer II XP Cardiac Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Approval for the Blazer II and Blazer II XP catheters with modified steering wire subassemblies. |
| P020050/S002 2/15/05 Real-Time |
WaveLight ALLEGRETTO WAVE™ Excimer Laser System | WaveLight Laser Technologie AG | Approval for Notebook software changes to the new software version (NB-042201) that involve: 1) a change in the notation used to enter refraction; and 2) the software menu location at which users may select different values for flap thickness based on the type of microkeratome used to create corneal flaps. |
| P030008/S002 2/15/05 Real-Time |
WaveLight ALLEGRETTO WAVE™ Excimer Laser System | Wavelight Laser Technologie AG | Approval for Notebook software changes to the new software version (NB-042201) that involve: 1) a change in the notation used to enter refraction; and 2) the software menu location at which users may select different values for flap thickness based on the type of microkeratome used to create corneal flaps. |
| P030025/S014 2/15/05 Special |
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for labeling changes that strengthen the instructions regarding appropriate methods to be used when a physician experiences withdrawal resistance following stent deployment and balloon deflation. |
| P030025/S015 2/15/05 Special |
PTCA Balloon Catheters, Express2™ Coronary Stent System and Taxus Express2™ | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval to add a specification for acceptable pyrogen level to the hypotube component. |
| P030030/S001 2/9/05 180-Day |
Tegress™ Urethral Implant | C.R. Bard, Inc. Covington, GA 30014 |
Approval for modification of the labeling to reflect a new device trade name. The device, as modified, will be marketed under the trade name Tegress™ Urethral Implant and is indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). |
| P040002/S001 2/15/05 180-Day |
Endologix PowerLink® System | Endologix, Inc. Irvine, CA 92618 |
Approval for the post-approval study protocol. |
P860057/S026 |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX, 6900P (PERIMOUNT Plus™), and 6900 PTFX |
Edwards Lifesciences LLC |
Addition of an additional semi-automatic torque machine and associated tooling. |
P870056/S019 |
Carpentier-Edwards® Bioprosthesis, Model 2625, 6625 and Valved Conduit Model 4300 |
Edwards Lifesciences LLC |
Addition of an additional semi-automatic torque machine and associated tooling. |
P870077/S017 |
Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis, Models 6625LP and 6625-ESR-LP |
Edwards Lifesciences LLC |
Addition of an additional semi-automatic torque machine and associated tooling. |
P950029/S023 |
Rate-Responsive Pacemakers Implantable Cardioverter Defibrillators |
ELA Medical, Inc. |
Change in sterilization process parameters. |
P980037/S012 |
AngioJet® Rheolytic Thrombectomy Catheter System |
Possis Medical, Inc. |
Change for the supply line nut of the AngioJet Pump Set. |
P980049/S018 |
Rate-Responsive Pacemakers Implantable Cardioverter Defibrillators |
ELA Medical, Inc. |
Change in sterilization process parameters. |
P000007/S006 |
Edwards Prima Plus Stentless Bioprosthesis 2500P |
Edwards Lifesciences LLC |
Addition of an additional semi-automatic torque machine and associated tooling. |
P000021/S005 |
Dimension® FPSA Flex® Reagent Cartridge |
Dade Behring, Inc. |
Change to decrease the quantity of rejected product. |
P000025/S018 |
COMBI 40+/PULSAR Cochlear Implant System |
Med-EL Corp. |
New silicone supplier. |
P010041/S006 |
Carpentier-Supraannular (S.A.V.®) Bioprosthesis Model 2650 |
Edwards Lifesciences LLC |
Addition of an additional semi-automatic torque machine and associated tooling. |
P020027/S002 |
Dimension® FPSA Flex® Reagent Cartridge |
Dade Behring, Inc. |
Change to decrease the quantity of rejected product. |
Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 45
Summary of PMA Originals Under Review
Total Under Review: 82
Total Active: 41
Total On Hold: 41
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 261
Total Active: 150
Total On Hold: 111
Number Greater Than 180 Days: 7
Summary of All PMA Submissions Received
Originals: 3
Supplements: 53
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 45
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 86.1
FDA Time: 61.4 Days MFR Time: 24.7 Days
Updated March 11, 2005
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
