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PMA Final Decisions Rendered for May 1999 |
 |
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 |
| P960016
5/4/99 |
Daig Livewire TC™ Steerable Electrophysiology Catheter | Daig Corporation
Minnetonka, MN 55345-2126 |
Approval for the Livewire TC™ Cardiac Ablation System. The device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator 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 a difficult to control ventricular response to an atrial arrhythmia. |
| P970015
5/14/99 |
INTER FIX™ Threaded Fusion Device | Sofamor Danek USA
Memphis, TN 38132 |
Approval of the INTER FIX™ Threaded Fusion Device. This device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INTER FIX™ implants are indicated to be used with autogenous bone graft and implanted via an open anterior approach. |
|
PMA SUPPLEMENTAL APPROVALS |
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|
APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
| N12159/S017
5/5/99 |
Surgicel Nu-Knit Fibrillar Absorbable Hemostat; Instat Collagen Absorbable Hemostat | Ethicon, Inc.
Somerville, NJ 08876 |
Approval for an additional location for final product release located at Ethicon, Inc., U.S. Route 22, Somerville, NJ 08876 and duplication of final packaging process at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico 00754. |
| N18033/S033
5/5/99 |
ACUVUE (etafilcon A) soft (hydrophilic) contact lens, clear and with visibility tint, with UV blocker, for extended wear | Vistakon™
Jacksonville, FL 32247 |
Approval for a change in the indications statement to add the sentence "ACUVUE UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye;" and modified Note and Warning. |
| P780010/S021
5/12/99 |
PERMALENS®, PERMALENS® THERAPEUTIC, PERMALENS® XL, AND PERMALENS® APHAKIC (perfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses | CooperVision
Scottsville, NY 14546 |
Approval for a consolidated package insert. |
| P790027/S064
5/13/99 |
IOLAB Brand UVBLOC™ Plus (LC) UV-Absorbing Posterior Chamber Intraocular Lens | Bausch & Lomb Surgical, Inc.
Clearwater, FL 33759 |
Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., 21 Park Place Blvd., North, Clearwater, FL 33759. |
| P810046/S195
5/19/99 |
ACS OTW Solaris™ Coronary Dilatation Catheter | Advanced Cardiovascular Systems, Inc.
Santa Clara, CA 95052 |
Approval for a new catheter model. |
| P830037/S041
5/20/99 |
DuraSoft® 3 UV (phemfilcon A) Spherical and Optifit Toric Clear, Handling Tint, Colors, and Color Complements Soft (hydrophilic) Contact Lens (lathe cut) for Extended Wear | Wesley-Jessen Corporation
Des Plaines, IL 60018 |
Approval for the DuraSoft® 3 UV (phemfilcon A) Spherical and Optifit Toric Clear, Handling Tint, Colors, and Color Complements Soft (hydrophilic) Contact Lens (lathe cut) for Extended Wear to incorporate the pigment carbazole violet as a handling tint at Wesley Jessen – Cidra Operation, Road 173, KM 1.1, Cidra, PR 00739. The pigment will be incorporated as an in-monomer tint by entrapment. |
| P830037/S042
5/7/99 |
FreshLook® Bifocal UV-absorbing Spherical (phemfilcon A) Handling Tint and Colors Soft (Hydrophilic) Contact Lenses for Extended Wear | Wesley Jessen Corporation
Des Plaines, IL 60018-5903 |
Approval for the following: 1) minor modification of the polymer formulation to include changes in the ratio of ingredients; 2) configuration change to include a bifocal design for the device; 3) modifications to the labeling to include the presbyopic indication and add the sentence "FreshLook® Lenses with UV-absorbing monomer help protect against the transmission of harmful UV radiation tot he cornea and into the eye"; 4) modification of the Note and Warning; 5) combining the package inserts for the bifocal, spherical and toric configurations; and 6) minor editorial changes to the spherical and toric indications. |
| P830055/S061*
5/19/99 |
LCS Total Knee System | DePuy Orthopaedics, Inc.
Warsaw, IN 46581-0988 |
Approval for the addition of the Rotating Platform Tibial Tray with Keel to the LCS® Total Knee System. |
| P830056/S079
5/11/99 |
Mentor Posterior Chamber Intraocular UV absorbing PMMA Lenses (Models: C451F, C421F, and C455A5) | Mentor Corporation
Santa Barbara, CA 93111 |
Approval for posterior chamber intraocular lens models C451F, C421F, and C455A5. These lenses are intended to be used for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag. |
| P830079/S012 | Surgicel Nu-Knit Fibrillar Absorbable Hemostat; Instat Collagen Absorbable Hemostat | Ethicon, Inc. | Approval for an additional location for final product release located at Ethicon, Inc. U.S. Route 22, Somerville, NJ 08876 and duplication of final packaging process at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico 00754. |
| P850059/S021
5/13/99 |
IOLAB Brand Model 2192 KELMAN™ OMNIFIT™ UVBLOC™ Plus (LC) UV-Absorbing Anterior Chamber Intraocular Lens | Bausch & Lomb Surgical, Inc.
Clearwater, FL 33759 |
Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., 21 Park Place Blvd., North, Clearwater, FL 33759. |
| P860005/S011
5/25/99 |
Pro Osteon® 500 Porous Hydroxyapatite Bone Graft Substitute | INTERPORE CROSS International
Irvine, CA 92618-2402 |
Approval for updated labeling that reflects the results of the completed post-market approval study. |
| P860019/S149
5/28/99 |
SCIMED® REMEDY™ Coronary Balloon Dilatation Infusion Catheter | Scimed Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval requested for the SCIMED REMEDY Coronary Balloon Dilatation Infusion Catheter . The device is indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion , and to infuse fluids such as heparinized saline, and thrombolytic agents such as urokinase, into the vasculature when the dilatation balloon is deflated or inflated to pressures up to 3 atm. The REMEDY™ catheter (2.5 – 4.0 mm balloon diameters)is also indicated for the post-delivery expansion of balloon expandable stents. |
| P860019/S153
5/11/99 |
SCIMED® PTCA Catheters | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for a sterilization facility located at Griffith Micro Science Wallonie, Zoning Industrial De Petit-Rechain, 4800 Verviers, Belgium. |
| P870013/S013
5/13/99 |
IOLAB Brand Model U85J UVBLOC™ Plus (PC) UV-Absorbing One-Piece Flexible Anterior Chamber Intraocular Lens | Bausch & Lomb Surgical, Inc.
Clearwater, FL 33759 |
Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., 21 Park Place Blvd., North, Clearwater, FL 33759. |
| P880047/S006
5/5/99 |
INTERCEED Absorbable Adhesion Barrier | Ethicon, Inc.
Somerville, NJ 08876 |
Approval for a manufacturing site located at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico. |
| P880047/S007
5/24/99 |
INTERCEED* (TC7) Absorbable Adhesion Barrier | Ethicon, Inc.
Somerville, NJ 08876-0151 |
Approval for revised labeling to reflect a recent study finding that, when used laparoscopically, INTERCEED*(TC7)-treated patients has more adhesions than patients in the control group. |
| P880086/S038
5/13/99 |
AddVent® VDDR Pacing System consisting of Models 2060BL and 2060LR pulse generators and the AV Plus® Model 1368 single-pass lead | St. Jude Medical
Sylmar, CA 91342 |
Approval for the AddVent® VDDR Pacing System consisting of Models 2060BL and 2060LR pulse generators and the AV Plus® Model 1368 single-pass lead. |
| P890023/S007*
5/10/99 |
Biomedics® 55 (ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens, clear and with visibility tint, for Extended Wear | Ocular Sciences, Inc.
Rockville, MD 20852 |
Approval for the addition of a ultraviolet blocker into the matrix of the Biomedics 55 (ocufilcon D) soft (hydrophilic) lens for extended wear, a change in the indications statement to add the sentence "Biomedics UV Blocking Contact Lenses help protect against transmission of harmful UV radiation of the cornea and in the eye;" and a modified Warning and Note. |
| P890055/S010*
5/27/99 |
Arrow Model 3000/3000-16/3000-50 Constant Flow Implantable Pump | Therex Corporation
Walpole, MA 02081 |
Approval for the following modifications:
|
| P900023/S029
5/19/99 |
ABIOMED® BVS 5000® Bi-Ventricular Support System | ABIOMED, Inc.
Danvers, MA 01923 |
Approval to modify the Operator's Manual to add information about transporting a patient to another institution while on BVS 5000 support, and to add information about the console display that has occurred during weaning from the device. |
| P900043/S016
5/27/99 |
PALMAZ- SCHATZ® MiniCrown Balloon-Expandable Stent with Dynasty™ Over the Wire delivery system | Cordis Corporation
Warren, NJ 07059 |
Approval for the addition of a label to the outside front panel of the MiniCrown carton that states the following: "Do not induce a vacuum on the delivery system prior to reaching the target lesion." |
| P930021/S001
5/18/99 |
EMDOGAIN® | Biora AB
SWEDEN |
Approval for manufacturing and packaging changes for EMDOGAIN®. |
| P940015/S004
5/26/99 |
Synvisc® (Hylan G-F 20) | Biomatrix, Inc.
Ridgefield, NJ 07657 |
Approval for labeling changes to the Physician Package Insert. The device, as modified, will be marketed under the trade name Synvisc® (Hylan G-F 20) and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. |
| P940031/S018*
5/6/99 |
Discovery and Meridian Pulse Generators | Guidant/CRM
St. Paul, MN 55112-5798 |
Approval for the introduction of an alternative lid for the accelerometer (to metal from ceramic) and the use of a silver thermoplastic to bond the accelerometer to the hybrid instead of epoxy. |
| P950014/S018*
5/19/99 |
Prostatron™ | EDAP Technomed, Inc.
Norcross, GA 30071 |
Approval for upgrades to the Prostasoft software to version 4.02 |
| P950035/S004
5/18/99 |
NeuroControl Freehand System | NeuroControl Corporation
North Attleboro, MA 02760 |
Approval for the following: 1) Changing the manufacturing site for the Epimysial Probe, Anode Plate, and Epimysial Electrode to Lewicki Microelectronic, GmbH; 2) Changing the site for packaging and sterilization of the Freehand System Electrode Positioning Kit and Epimysial Electrode to Lewicki Microelectronic , GmbH; 3) Addition of two paper measuring tapes to the Electrode Positioning Kit; 4) Changing the materila used to support the Anode Plate and the coating over this material; 5) Changing the material used to coat the weld of the Epimysial Electrode; 6) Changing the vendor for the connector pin, strain relief springs, and center springs of the Implantable Connector of the Epimysial Electrode; 7) Changing the manufacturing procedures, packaging, and sterilization process; and 8) Changing the labeling to include symbols that conform to European CE Marketing requirements. |
| P960040/S009
5/3/99 |
VENTAK® VR AICD™ System with Model 2841 Software, Version 1.4 | Guidant Corporation
St. Paul, MN 55112-5798 |
Approval for the VENTAK® VR AICD™ System with Model 2841 Software, Version 1.4 |
| P960043/S007
5/5/99 |
Prostar® XL 8F Percutaneous Vascular Surgical (PVS) System | Perclose, Inc.
Menlo Park, Ca 94025 |
Approval for an additional effectiveness claim (i.e., reduced time to discharge) for the Prostar® XL 8F Percutaneous Vascular Surgical (PVS) System. The device will be marketed under the trade name Prostar® XL 8F Percutaneous Vascular Surgical (PVS) System and is now indicated for: "the percutaneous delivery of sutures for closing the common femoral artery access site and reducing time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 6.5 Fr. to 8 Fr. Sheaths. The Prostar XL 8 Fr. System reduces the time to discharge in patients having undergone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations)." |
| P960043/S009
5/5/99 |
Techstar® XL 6F Percutaneous Vascular Surgical (PVS) System | Perclose, Inc.
Menlo Park, CA 94025 |
Approval for additional effectiveness claims (i.e., reduced time to ambulation and reduced time to discharge) for the Techstar® XL 6 Fr. Percutaneous Vascular Surgical (PVS) System. The device will be marketed under the trade name Techstar XL 6F Percutaneous Vascular Surgical (PVS) System and is now indicated for: "the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to ambulation (patient walks ten feet) of patients who have undergone diagnostic catheterization procedures using 5 Fr. to 6 Fr. Sheaths. The Techstar XL 6 Fr. PVS System reduces the time to discharge in patients having undegone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations)." |
| P960043/S016
5/28/99 |
Techstar® XL and Prostar® XL Percutaneous Vascular Surgical (PVS) Systems | Perclose, Inc.
Menlo Park, CA 94025 |
Approval for modifications to the instructions for use to include an alternative surgical knot. |
| P960043/S017
5/5/99 |
Techstar® XL and Prostar® XL Percutaneous Vascular Surgical (PVS) System | Perclose, Inc.
Redwood City, CA 94063 |
Approval for modifications to the labeling and placement of the outer package label. |
| P960043/S018
5/26/99 |
Techstar® XL and Prostar® XL Percutaneous Vascular Surgical (PVS) Systems | Perclose, Inc.
Redwood City, CA 94063 |
Approval for the use of an additional package label identifying the sterile barrier. |
| P970003/S022*
5/5/99 |
NeuroCybernetic Prosthesis (NCP®) System, Model 101 NCP Pulse Generator | Cyberonics, Inc.
Houston, TX 77058 |
Approval for the Model 101 NCP Pulse Generator (for use with Model 201 NCP Programming Wand and Model 250 NCP Programming Software Version 4.4). |
| P970008/S011
5/3/99 |
Urologix Targis™ System | Urologix, Inc.
Minneapolis, MN 55447 |
Approval for modifications to the software to 1) add the cruise control option to the Targis™ System treatment and 2) make minor changes to the operation of the coolant system. |
| P970020/S011
5/6/99 |
ACS MULTI-LINK RX and OTW DUET™ Coronary Stent Systems | Guidant Corporation
Santa Clara, CA 95052 |
Approval for a 5-year post-approval study protocol for the ACS MULTI-LINK RX and OTW DUET™ Coronary Stent Systems. |
| P970043/S003
5/12/99 |
LADAR Vision® Excimer Laser System | Autonomous Technologies Corporation
Orlando, FL 32826 |
Approval for labeling changes (i.e., minor editorial changes and the addition of a precaution statement to the Patient Information Booklet, Physicians' Booklet, and System Operation Manual. The System Operation Manual also included some revised instructions for use, including directions to follow in the event of a power interruption before or during treatment). |
| P970051/S005*
5/12/99 |
Nucleus 24 Cochlear Implant System | Cochlear Corporation
Englewood, CO |
Approval for a longer two meter cable for use with the H58 handset in the Nucleus 24 Cochlear Implant System. |
| P980001/S001
5/20/99 |
NIR™ Primo™ Premounted Stent System | Boston Scientific Corporation
Natick, MA 01760-1537 |
Approval for the NIR Primo Premounted Stent System. |
| P980003/S002*
5/6/99 |
Chilli® Cooled Ablation System | Cardiac Pathways Corporation
Sunnyvale, CA 94086 |
Approval for hardware and software changes made to support a single board computer, as well as software changes to allow the use of user-selected flow rates for the pump. |
* Evaluated as a "Real-Time Review" PMA Supplement.
|
APPLICATION NUMBER / DATE of APPROVAL |
|
COMPANY NAME |
|
| P840024/S078**
5/7/99 |
Nucleus 22 Channel Cochlear Implant System (Adult) | Cochlear Corporation
Englewood, CO 80112 |
The 30-day Notice requested a manufacturing process change from Freon to Lenium TS for use in the expansion of silicone tubing and moldings. |
| P890027/S047**
5/7/99 |
Nucleus 22 Channel Cochlear Implant System (Child) | Cochlear Corporation
Englewood, CO 80112 |
The 30-day Notice requested a manufacturing process change from Freon to Lenium TS for use in the expansion of silicone tubing and moldings. |
| P940034/S010**
5/25/99 |
Gen-Probe® Amplified Mycobacterium Tuberculosis Direct Test | Gen-Probe, Inc.
San Diego, CA 92121-4362 |
30-day Notice for the following changes: revised performance specifications for specific materials and the addition of qualified vendors; and implementation of additional in-process qualification procedures for testing oligonucleo tide materials. |
| P970020/S014**
5/14/99 |
ACS MULTI-LINK Coronary Stent Systems/ACS MULTI-LINK DUET Coronary Stent Systems | Guidant Corporation
Temecula, CA 92591-4628 |
The 30-Day Notice requested a change in the manufacturing operation for the stent systems packaging. |
| P970020/S015**
5/20/99 |
ACS MULTI-LINK Coronary Stent Systems/ACS MULTI-LINK DUET Coronary Stent Systems | Guidant Corporation
Santa Clara, CA 95054 |
30-day Notice to modify the process by which the stents are passivated and include four other minor changes. |
| P970035/S016**
5/14/99 |
GFX® 2 Coronary Stent System | Medtronic AVE, Inc.
Santa Rosa, CA 95403 |
The 30-Day Notice requested that GFX® ring components annealed at 985 degrees Celsius for 20 minutes be utilized for the manufacturing of the GFX2 stent component. The change is being requested in order to utilize the existing inventory of GFX ring components for the manufacture of GFX2 stent. |
| P970051/S006**
5/7/99 |
Nucleus 24 Cochlear Implant System | Cochlear Corporation
Englewood, CO 80112 |
The 30-day Notice requested a manufacturing process change from Freon to Lenium TS for use in the expansion of silicone tubing and moldings. |
**A 135 Day Supplement Was Not Required
Correction to 5/13/99 Approval List
Correction Added June 2001
PMA Supplemental Approvals
|
APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
|
P790027/S060 5/13/99 180-Day |
IOLAB Brand UVBLOC™ Plus (LC) UV-Absorbing Posterior Chamber IOL |
Bausch & Lomb Surgical, Inc. Clearwater, FL 33759 |
Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., Clearwater, Florida. |
|
P850059/S017 5/13/99 180-Day |
IOLAB Brand Model 2192 KELMAN™ OMNIFIT™ UVBLOC Plus (LC) UV-Absorbing Anterior Chamber IOL |
Bausch & Lomb Surgical, Inc. Clearwater, FL 33759 |
Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., Clearwater, Florida. |
|
P870013/S009 5/13/99 180-Day |
IOLAB Brand Model U85J UVBLOC™ Plus (PC) UV-Absorbing One-Piece Flexible Anterior Chamber IOL |
Bausch & Lomb Surgical, Inc.Clearwater, FL 33759 |
Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., Clearwater, Florida. |
Summary of PMA Originals & Supplements Approved
Originals:2
Supplements:40
Summary of PMA Originals Under Review
Total Under Review:75
Total Active:37
Total On Hold:38
Number Greater Than 180 Days:01
Summary of PMA Supplements Under Review
Total Under Review:192
Total Active:127
Total On Hold:65
Number Greater Than 180 Days:6
Summary of All PMA Submissions Received
Originals:5
Supplements:40
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals:40
Number of Denials:0
Average Days Fr Receipt to Decision (Total Time):139
Number Greater Than 180 Days:6
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