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PMA Final Decisions Rendered for March 2004 |
Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
3/15/04 |
OSTEOSPACE |
MEDILINK Carnon, France F34280 |
Approval for the OSTEOSPACE. The OSTEOSPACE is a quantitative ultrasound bone sonometer device (QUS) to be used for the measurement of broadband ultrasound attenuation (BUA) of the calcaneus, as an aid, together with other clinical risk factors, to diagnose osteoporosis and other medical conditions leading to reduced bone strength and to estimate the risk of subsequent atraumatic fracture. The output is expressed in terms of BUA, T-score, and Z-score. |
3/4/04 |
Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator |
Ortho-Clinical Diagnostics, Inc. |
Approval for the Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator. These devices are indicated for: 1) Vitros Immunodiagnostic Products Anti-HBc Reagent Pack is indicated for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human adult and pediatric serum and plasma (EDTA and citrate) and neonate serum 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, or recovery from hepatitis B infection. The presence of anti-HBc may be used as an aid in the determination of exposure to HBV infection for individuals prior to HBV vaccination. 2) Vitros Immunodiagnostic Products Anti-HBc Calibrator is indicated for use in the calibration of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human adult and pediatric serum and plasma (EDTA and citrate) and neonate serum using Vitros Anti-HBc Reagent Packs.. |
3/4/04 |
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) |
Boston Scientific Corporation Natick, MA 01760 |
Approval for the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire). The device is indicated for improving luminal diameter for the treatment of de novo lesions <28 mm in length in native coronary arteries ≥ 2.5 to ≤ 3.75 mm in diameter. |
3/4/04 |
Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator |
Ortho-Clinical Diagnositc, Inc. Rochester, NY 14626 |
Approval for the Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator. These devices are indicated for: 1) Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack is indicated for the in vitro qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human adult and pediatric serum and plasma (heparin, EDTA and citrate) and neonate serum 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. 2) Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator is indicated for the use in the calibration of the Vitros Immunodiagnostic System for the in vitro qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human adult and pediatric serum and plasma (EDTA, heparin or citrate) and neonate serum using Vitro Anti-HBc IgM Reagent Packs. |
PMA Supplemental Approvals
P810046/S214 3/12/04 180-Day |
VOYAGER™ OTW Coronary Dilatation Catheter |
Guidant Corporation Temecula, CA 92591 |
Approval for a new coronary dilatation catheter. The device, as modified, will be marketed under the trade name VOYAGER™ OTW Coronary Dilatation Catheter and is indicated for 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, 3) balloon dilatation of a stent after implantation. |
P840064/S025 3/5/04 Real-Time |
DUOVISC® Viscoelastic System |
Alcon Laboratories Fort Worth, TX 76134 |
Approval to modify the pH release and stability specification ranges for PROVISC® Ophthalmic Viscosurgical Device contained within the DUOVISC® Viscoelastic System from pH 7.0-7.3 to pH 7.0-7.4 for release and pH 7.0-7.5 to pH 6.8-7.5 for stability. |
P860004/S059 3/17/04 Real-Time |
SynchroMed and SynchroMed II Implantable Infusion Pumps |
Medtronic Neurological Minneapolis, MN 55432 |
Approval for: the addition of time labels and a daily dose filed to the programming screens; the addition of recently approved catheter models, Model 8731 and Model 8749, to the drop-down list; changes to the screen used to enter the DEMO mode, and the resulting updates to the programming guides. |
P860004/S060 3/29/04 Real-Time |
SynchroMed® II Programmable Drug Infusion System |
Medtronic, Neurological Minneapolis, MN 55432 |
Approval for the following changes involving the motor coil for the SynchroMed® II Implantable Infusion Pump: 1) change from a crimped to a heat-welded motor coil connector pin; and 2) change to a silicon varnish surface coating of the motor coil, the same coating as applied to the motor coil of the SynchroMed® El Implantable Infusion Pump. |
P880070/S010 3/17/04 Real-Time |
Model HSM65 UV Absorbing PMMA Anterior Chamber Lens |
Pharmacia & Upjohn Company Pickerington, OH 43147 |
Approval to change the material and the manufacturing process, to add a heparin surface modification, and to change the lens model designation form UV65B to HSM65. |
P890003/S074 3/8/04 Real-Time |
Medtronic Model 2490D CareLink Monitors and Model 2491 DDMA Software for EnPulse Models E2DR01, E1DR03, E1DR06, E1DR21, E2VDD01, E2SR01, E2SR03, E2SR06, E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33 and Kappa Models 600/700/800/900 devices |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Model 2490D CareLink Monitor and Model 2491 DDMA Software to allow their use with EnPulse and Kappa devices. The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection. |
P890047/S016 3/5/04 Real-Time |
PROVISC® Ophthalmic Viscosurgical Device |
Alcon Laboratories Fort Worth, TX 76134 |
Approval to modify the pH release and stability specification ranges for PROVISC Ophthalmic Viscosurgical Device contained within the DUOVISC Viscoelastic System from pH 7.0-7.3 to pH 7.0-7.4 for release and pH 7.0-7.5 to pH 6.8-7.5 for stability. |
P890055/S018 3/25/04 Real-Time |
Codman Series 3000 Implantable Infusion Pumps |
Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval for the following: minor design and material modifications to the connector; addition of a silicone strain relief sleeve; and minor design and material modifications to the anchors. |
P900009/S018 3/12/04 Real-Time |
Exogen 2000+ and Exogen 3000 |
Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for two design and component changes: 1) Changes to Exogen 2000+ printed circuit board to implement corrective action for field failure and returns. This corrective action involves two design changes: i) Replace 2 diodes on te printed circuit board with light emitting diodes. ii) Add a 1000 pF capacitor to reduce electrical noise. 2) Replace both Exogen 2000+ and Exogen 3000 transducer cables with a more cost effective model. |
P900043/S042 3/4/04 180-Day |
Bx VELOCITY™ Stent with Raptor™ Over-the-Wire (OTW) or RAPTORRAIL™ (RX) Stent Delivery Systems (SDS) – Saphenous Vein Graft (SVG) Indication |
Cordis Corp. Miami Lakes, FL 33014 |
Approval for a new Saphenous Vein Graft (SVG) Indication for the Bx VELOCITY™ Stent with Raptor™ Over-the-Wire (OTW) or RAPTORRAIL™ (RX) Stent Delivery Systems (SDS). The device is indicated for the treatment of: Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (< 30 mm in length) in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm; 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; and, Patients with de novo or restenotic saphenous vein graft lesions (< 30 mm in length) with reference diameters ranging from 3.0 mm to 5.0 mm |
P910007/S006 3/3/04 180-Day |
Abbott AxSYM® Total PSA |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Health Products, Inc., Barceloneta, Puerto Rico. |
P910073/S043 3/2/04 Real-Time |
ENDOTAK® RELIANCE ® G/SG Lead Models 0180-0187 |
Guidant Corporation St. Paul, MN 55112 |
Approval for addition of an ePTFE coating to the shock coils. The device, as modified, will be marketed under the trade name ENDOTAK® RELIANCE® G/SG Lead Models and is indicated for providing pacing and rate-sensing and to deliver cardioversion and defibrillation shocks for ICD automatic implantable cardioverter defibrillator systems. |
P930038/S037 3/24/04 180-Day |
Trac-Sure™ Tissue Tract Accessory |
St. Jude Medical, Inc. Minnetonka, MN 55345 |
Approval for the Trac-Sure™ Tissue Tract Accessory device. The Trac-Sure Tissue Tract Accessory is indicated for use in conjunction with the Angio-Seal STS and Angio-Seal STS Plus Vascular Closure Devices in instances where puncture site tissue tract bleeding is noted after hemostasis is achieved with either of these two Angio-Seal devices. This accessory is an aid in managing puncture site tissue tract non-pulsatile bleeding which occurs after hemostasis is achieved with the Angio-Seal STS or STS Plus Vascular Closure Devices. |
P950019/S014 3/25/04 180-Day |
Ray TFC and Ray TFC Unite |
Stryker Howmedical Osteonics Allendale, NJ 07401 |
Approval for a manufacturing site located at Stryker Spine, Cestas, France. |
P950037/S032 3/31/04 180-Day |
Protos DR/CLS, Protos VR/CLS, Axios DR, Axios D, Axios S, Axios SR, and Axios SLR Pulse Generators with Programmer Software Version SWM 1000 B-K00.PU and Data Transfer Utility v1.0 |
BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Approval for adding AxVx adaptive rate pacing capability to the Protos family of pulse generators, the addition of the Data Transfer Utility software, and modifications to the Axios family of pulse generators. |
P950037/S034 3/8/04 180-Day |
Selox SR Steroid-Eluting Active Fixation Endocardial Pacing Lead Models SR45, SR53, SR60 |
BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Approval for addition of a drug collar to the pacing lead. The device, as modified, will be marketed under the trade name Selox SR and is indicated as following: Botronik’s SELOX SR transvenous, steroid-eluting, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems. The SELOX SR lead models are intended for placement in either the right atrium or right ventricle. |
P950037/S036 3/31/04 180-Day |
Philos II DR, Philos II D, Philos II DR-T, Philos II SLR, Philos II SR, Philos II S, and programmer software version A-K00.2.U |
BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Approval for additional features added to the Philos family of pacemakers. The device, as modified, will be marketed under the trade name Philos II and is indicated as follows: Rate-adaptive pacing with the Philos II pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing. Philos II SLR pulse generators are primarily intended to provide VDD or VDDR pacing for patients with a healthy sinus node and AV conduction abnormalities. These modes are indicated for patients who need ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This includes the presence of complete AV block when: 1) Atrial contribution is needed for hemodynamic benefit and 2) Pacemaker syndrome had existed or is anticipated. Additional indications include normal sinus rhythm and normal AV conduction in patients who intermittently need ventricular pacing support. |
P950037/S037 3/31/04 Real-Time |
Philos DR-T Pulse Generator and A-K00.1.U/5 Programmer Software |
BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Approval for the addition of two Cardio Report triggers for the Philos DR-T pulse generator and for revisions to the A-K00.1.U/5 Programmer Software which are necessary in order to utilize the modified Philos DR-T. |
P960025/S010 3/17/04 180-Day |
Lumbar I/F Cage System |
DePuy AcroMed Raynham, MA 20767 |
Approval for a manufacturing site located at DePuy AcroMed Sarl, LeLocle, Switzerland. |
P960025/S011 3/5/04 180-Day |
Saber Lumbar I/F Cage, Jaguar Lumbar I/F Cage |
DePuy Acromed, Inc. Raynham, MA 02767 |
Approval for the Saber Lumber I/F Cage. In addition, this supplement requested the approval of two new sizes, which will now be marketed as the Jaguar Lumbar I/F Cage. These devices are indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360 degrees fusion) and posterior pedicle screw fixation . These patients may have had previous non-fusion spinal surgery at the involved spinal levels(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. |
P960040/S039 3/8/04 Real-Time |
Vitality 2 AICD System (Models T165, T167, T175, T177), Model 2857 Application Software (Version 2.2) and Quick Profiles Disk (Model 2828 Version 1.0) |
Guidant Corporation St. Paul, MN 55112 |
Approval for the VITALITY™ 2 ICD system (Models T165, T167, T175, T177), Model 2857 Application Software (Version 2.2), and Quick Profiles Disk (Model 2828 Version 1.0). The device is indicated for use in the following: Guidant ICDs are intended to provide therapy for the automated treatment of life-threatening ventricular arrhythmias. Patient populations who are indicated for a Guidant ICD include: 1) Those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or 2) Patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction of ≤ 30%. |
P960040/S041 3/9/04 Real-Time |
VENTAK PRIZM® AICD system (Models 1850, 1851, 1855, 1856), VENTAK PRIZM® HE AICD system (Models 1852, 1853, 1857, 1858), VENTAK PRIZM® 2 AICD system (Models 1860, 1861), VITALITY® DS/EL AICD system (Models T125, T127, T135), application Software Model 2844 Version 3.7 |
Guidant Corporation St. Paul, MN 55112 |
Approval for the firmware modifications of the following AICD systems: VENTAK PRIZM® AICD system (Models 1850, 1851, 1855, 1856) firmware version 1.2 Patch H, VENTAK PRIZM® HE AICD system (Models 1852, 1853, 1857, 1858) firmware version 1.2 Patch H, VENTAK PRIZM® 2 AICD system (Models 1860, 1861) firmware version 1.4 Patch C, VITALITY® DS/EL AICD system (Models T125, T127, T135) firmware version 1.0 Patch B, CONTAK CD® 2 (Models H115, H119) firmware version 1.2 Patch H, and the Application Software Model 2844 Version 3.7. |
P960040/S042 3/19/04 Real-Time |
VENTAK VITALITY® AVT AICD System (Model A135) |
Guidant Corporation St. Paul, MN 55112 |
Approval for the System Guide labeling reinsert (Change Tachy Mode with Magnet feature). |
P960043/S052 3/18/04 Real-Time |
Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) System |
Abbott Vascular Devices Perclose, Inc. Redwood City, CA 94063 |
Approval for changing to a new suture vendor (Surgipro II Monofilament Polypropylene Suture.) |
P970020/S045 3/22/04 180-Day |
Multi-Link Coronary Stent System |
Guidant Corporation Temecula, CA 92591 |
Approval for a sterilization site located at Guidant Corporation, Guidant Ireland, Clonmel, Ireland. |
P980016/S040 3/8/04 Real-Time |
Medtronic Onyx System, Device Model 7290Cx and Software Model 9999 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for device modifications to the GEM II/II I VR Systems. The device, as modified, will be marketed under the trade name Medtronic Onyx System, Device Model 7290Cx and Software Model 9999 and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. |
P980023/S016 3/12/04 Real-Time |
Kentrox SL ICD Leads Model 65/16, 65/18, 75/16, 75/18, 100/16, 100/18 |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for changes in component dimensions. The device, as modified, will be marketed under the trade name Kentrox SL and is indicated for use in conjunction with a BIOTRONIK ICD. Currently, data is not available regarding the use of this lead system with ICDs of other manufacturers. Use of other ICDs may adversely affect sensing and/or therapy delivery. |
P980035/S035 3/8/04 Real-Time |
Medtronic Model 2490D CareLink Monitors and Model 2491 DDMA Software for EnPulse Models E2DR01, E1DR03, E1DR06, E1DR21, E2VDD01, E2SR01, E2SR03, E2SR06, E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33 and Kappa Models 600/700/800/900 devices |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Model 2490D CareLink Monitor and Model 2491 DDMA Software to allow their use with EnPulse and Kappa devices. The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection. |
P980035/S036 3/31/04 Real-Time |
EnPulse™ Implantable Pulse Generator, Models E1DR01, E1DR03, E1DR06, E1DR21 and Model 9991 v 2.0 Application Software | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the addition of the Atrial Capture Management (ACM) and Post Mode Switch Overdrive Pacing (PMOP) features to EnPulse™ Implantable Pulse Generator Models E1DR01, E1DR03, E1DR06, and E1DR21. In addition, you requested approval for minor updates to the associated programmer software. The device, as modified, will be marketed under the trade name EnPulse™ Implantable Pulse Generator Models E1DR01, E1DR03, E1DR06, E1DR21 and Model 9991 v 2.0 Application Software. |
P980049/S012 3/15/04 Special |
Alto DR Model 614, Alto VR Model 615, Alto 2 DR Model 624 and Alto 2 VR Model 625 | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for changes to the labeling to include a more accurate battery longevity data. |
P980049/S013 3/16/04 Real-Time |
Elaview 1.22 UG1 application software, RAM Patch P2, RAM Patch TI V5, HSO 2.68 software and V10+ hardware for the CPR3 Programming Head | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for Elaview 1.22 UG1 application software for the Orchestra programmer, RAM Patch P2 for Alto 2 ICD system, RAM Patch TI V5 for Symphony and ELA Rhapsody pacemakers, and HSO 2.68 software and V10+ hardware for the CPR3 Programming Head. |
P990033/S005 3/15/04 180-Day |
PepGen P-15, PepGen P-15 Flow, and PepGen P-15 Putty | Dentsply CeraMed Dental Lakewood, CO 80228 |
Approval for: 1) The addition of a paste form of PepGen P-15, 2) Modification of the device labeling for all PepGen P-15 devices, and 3) Changing of the contract manufacturer for the device carrier to Hyaluron, Inc., Woburn, Massachusetts. |
P990080/S004 3/1/04 180-Day |
Foldable Ultraviolet Light-absorbing Posterior Chamber IOL, Tecnis™, with Z-sharp™ Optic Technology, Model Z9000 | Pharmacia and Upjohn Company Kalamazoo, MI 49001 |
Approval to revise the package insert with claims regarding reduction in postoperative spherical aberrations compared to lenses with spherical optics and improved night driving simulator performance. The device, as modified, will be marketed under the trade name Tecnis™ and is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsifi-cation. The lenses are intended to be placed in the capsular bag. |
P000009/S008 3/19/04 180-Day |
Belos A+ and Belos A+/T ICD and Kainox A+ ICD Lead (single-lead system) | BIOTRONIK, Inc. Lake Oswego, OR 97035 |
Approval for the Belos A+ and Belos A+/T ICD and Kainox A+ ICD Lead (single-lead system). It is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. |
P000032/S004 3/31/04 180-Day |
Her Option™ Cryoblation Therapy System | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for a manufacturing facility located at American Medical Systems, Inc., Minnetonka, Minnesota. |
P000052/S021 3/4/04 135-Day |
GALILEO III Intravascular Radiotherapy Systems | Guidant Corporation Houston, TX 77054 |
Approval for a change to the P-32 Source Wire Manufacturing Process to incorporate an automated Source Wire Assembly Station (SWAS) as an alternate process for final assembly of P-32 Source Wires. |
P000052/S023 3/16/04 Real-Time |
GALILEO III Intravascular Radiotherapy Systems | Guidant Corporation Houston, TX 77054 |
Approval to implement a new software revision, Version 63-033/N. The software was revised to increase the Distal Stop Force of the Active Source Wire. |
P000053/S002 3/16/04 Real-Time |
AMS Sphincter 800™ Urinary Control System | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for revision of the labeling to describe an alternate surgical approach (i.e., transverse scrotal implantation). |
P000058/S007 3/30/04 Special |
INFUSE™ Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for a modification to the package insert. Specifically, adding the following additional events to the “Possible Adverse Events” section of the insert: “Edema (swelling), inflammation, erythematous, allergic reaction, dysphasia, itching, anaphylactic reaction, elevated erythrocyte sedimentation rate, pain, hematoma.” |
P010012/S023 3/9/04 Real-Time |
CONTAK CD® 2 (Models H115, H119) and application software Model 2844 Version 3.7 | Guidant Corporation St. Paul, MN 55112 |
Approval for the firmware modifications of the following AICD systems: VENTAK PRIZM® AICD system (Models 1850, 1851, 1855, 1856) firmware version 1.2 Patch H, VENTAK PRIZM® HE AICD system (Models 1852, 1853, 1857, 1858) firmware version 1.2 Patch H, VENTAK PRIZM® 2 AICD system (Models 1860, 1861) firmware version 1.4 Patch C, VITALITY® DS/EL AICD system (Models T125, T127, T135) firmware version 1.0 Patch B, CONTAK CD® 2 (Models H115, H119) firmware version 1.2 Patch H, and the Application Software Model 2844 Version 3.7. |
3/16/04 180-Day |
ViewPoint™ CK® System |
Refractec, Inc. Irvine, CA 92618 |
Approval for the ViewPoint™ CK® System. The device is indicated for the temporary induction of myopia (-1.00 D to -2.00 D) to improve near vision in the non-dominant eye of presbyopic hyperopes or presbyopic emmetropes, via spherical hyperopic treatment of 1.00 to 2.25 D, in patients: 1) 40 years of age of greater; 2) with a documented stability of refraction for the prior 12 months, as demonstrated by a change of <0.50 D in spherical and cylindrical components of the manifest refraction; 3) with <=0.75 D of cycloplegic refractive cylinder; and 4) with a successful preoperative trial of monovision or history of monovision wear (i.e., dominant eye corrected for distance vision and non-dominant eye corrected for near vision). |
P010025/S004 3/2/04 Real-Time |
Selenia Full Field Digital Mammography System |
Lorad, A Hologic Co. Danbury, CT 06810 |
Approval for Selenia FFDM system for use in a mobile environment and QC Manual changes. |
P010059/S001 3/15/04 180-Day |
Alcon® ReFORM® Capsular Tension Rings |
Morcher GmbH Stuttgart, Germany D-70374 |
Approval for a private label distributor agreement with Alcon Laboratories, Inc., Fort Worth, Texas. The device will be marketed under the trade name Alcon ReFORM Capsular Tension Rings (Models ACTR10, ACTR11, and ACTR12). |
P020036/S002 3/19/04 Real-Time |
S.M.A.R.T.™ Control™ Nitinol Stent System |
Cordis Corporation Miami Lakes, FL 33014 |
Approval for the following change to the deliver system of the S.M.A.R.T.™ Control™ Nitinol Stent System: 1) The wire lumen of the delivery system will be fabricated from different materials. 2) The new wire lumen inner diameter specification has been increased. 3) The proximal land section of the distal tip has been increased. 4) The inner diameter specification of the distal tip has been increase. |
P020047/S002 3/22/04 180-Day |
Multi-Link Vision Coronary Stent System |
Guidant Corporation Temecula, CA 92591 |
Approval for a sterilization site located at Guidant Corporation, Guidant Ireland, Clonmel, Ireland. |
30-Day Notices (135 Day Supplement was not required)
P930039/S018 3/10/04 |
Medtronic Model 5076 Lead |
Medtronic, Inc. Minneapolis, MN 55432 |
Use of Med-2000 silicone adhesive as an alternative for Med-1137 silicone adhesive. |
P960022/S004 3/4/04 |
Softlens66® Toric (alphafilcon A) Visibility tinted Contact Lens |
Bausch and Lomb Rochester, NY 14609 |
Addition of an automated inspection process for the Softlens66®. |
P970003/S053 3/3/04 |
VNS Therapy™ System |
Cyberonics, Inc. Houston, TX 77058 |
Changes in the manufacturing process to propose using Cyberonics, Inc. as an additional in-house facility for bioburden testing on products and reducing the frequency of sampling of tunneling tools and accessory packs. |
P970003/S054 3/3/04 |
VNS Therapy™ System |
Cyberonics, Inc. Houston, TX 77058 |
Manufacturing process change to reduce the minimum vacuum bake process time for the Cyberonics Models 102/102R pulse generators. |
D970012/S020 3/24/04 |
AMS 700 Series Product Line Inflatable Penile Prosthesis |
American Medical Ssytems Minnetonka, MN 55343 |
Change in molding vendors, from in-house production to purchase form an outside vendor. |
P990041/S005 3/26/04 |
Diasorin ETI-AB-EBK PLUS™ |
DiaSorin, Inc. Stillwater, MN 55082 |
Change in the quality control test of an incoming raw material used in the preparation of Coated Strips of the ETI-AB-EBK PLUS™ which is an in vitro enzyme immunoassay intended for use in the qualitative determination of total antibodies to hepatitis B e antigen in human serum or plasma. |
P990043/S006 3/26/04 |
Diasorin ETI-EBK PLUS™ |
DiaSorin, Inc. Stillwater, MN 55082 |
Change in the quality control test of an incoming raw material used in the preparation of Coated Strips of the ETI- EBK PLUS™ which is an in vitro enzyme immunoassay intended for use in the qualitative detection of hepatitis B e antigen in human serum or plasma. |
P000029/S006 3/1/04 |
Deflux Injectable Gel |
Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Changes in bioburden test site from an external lab to in-house, an identity test method for a raw material, and specification limits for a raw material. |
P000049/S011 3/24/04 |
CardioSEAL® Septal Occlusion System with Qwik Load |
NMT Medical, Inc. Boston, MA 02210 |
Change in the manufacturing process of the CardioSEAL® Septal Occlusion System with Qwik Load which involves a change to the bioburden sampling plan to eliminate redundant quarterly testing. |
P000053/S003 3/24/04 |
AMS 800 Urinary Control System |
American Medical Systems Minnetonka, MN 55343 |
Change in molding vendors, from in-house production to purchase form an outside vendor. |
P010020/S001 3/24/04 |
AMS Acticon Neospnincter |
American Medical Systems Minnetonka, MN 55343 |
Change in molding vendors, from in-house production to purchase form an outside vendor. |
P020003/S002 3/18/04 |
Saline-Filled Testicular Prostheses |
Mentor Corporation Santa Barbara, CA 93111 |
Change involving the engraving process, a change in a raw material supplier and a minor change in the molding process. |
P020023/S003 3/3/04 |
Restylane Injectable Gel |
Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Changes in the Restylane raw material, sodium hyaluronate. |
P030005/S001 3/3/04 |
CONTAK RENEWAL TR, Models H120 and H125 |
Guidant Corporation St. Paul, MN 55112 |
Change in the method that is used to release sterilized product, from the use of biological indicators to parametric release. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 45
Summary of PMA Originals Under Review
Total Under Review: 88
Total Active: 45
Total On Hold: 43
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 199
Total Active: 103
Total On Hold: 96
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 6
Supplements: 66
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): 137.6
FDA Time: 84.3 Days MFR Time: 53.3 Days
Updated January 21, 2005
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