PMA Final Decisions Rendered for April 1998

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PMA Final Decisions Rendered for April 1998

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 for April 1998. This list is generated on a monthly basis.

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.

PMA Original Approvals

APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
P940025 4/30/98	Lobob W/RW Drop	Lobob Laboratories, Inc.	Indicated for use to wet fluoro-silicone acrylate and silicone acrylate rigid gas permeable contact lenses prior to insertion and to lubricate lenses while they are on the eye.
P940026 4/28/98	Lobob C/D/S Cleaning, Disinfecting and Storage Solution	Lobob Laboratories, Inc.	Indicated for use in the cleaning, chemical disinfection and storage of fluoro-silicone acrylate and silicone acrylate rigid gas permeable contact lenses.
P950031 4/3/98	LOBOB CLEANER	Lobob Laboratories, Inc.	Indicated for use to clean silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses and all hard contact lenses.
P970032 4/29/98	SalEst™	Biex, Inc. Dublin, CA 94568	Approval for the SalEst™ . This device is intended to detect and measure by enzyme-linked immunoabsorbant assay (ELISA) technology the level of salivary estriol in pregnant women. The device is indicated for use as an aid in identifying risk of spontaneous preterm labor and delivery in singleton pregnancies. The device can be used every 1 to 2 weeks from gestational ages 22 to 36 weeks. The test should be used as a component of the clinician's assessment of risk for preterm labor and delivery.

PMA Supplemental Approvals

APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
N50510/S080 4/14/98	Vitek Systems "General Susceptibility Card"	Biomerieux Vitek, Inc. Hazelwood, MO 63042	Approval for the addition of a limitation to use an alternative method to confirm results for the testing of Pseudomonas aeruginosa with the antibiotic cefepime. The device, as modified, will be marketed under the trade name Vitek Gram Negative Susceptibility Card in three concentrations (equivalent to 4, 8 and 16 ug/ml) and is indicated for the testing of rapidly growing aerobic and/or facultatively anaerobic gram negative bacilli.
P8600004/S040 4/13/98	Medtronic® SynchromMed™ Infusion System	Medtronic Neurological Minneapolis, MN 55440-9087	Approval to modify the prescription caution statement on the SynchroMed product labeling from "Caution: Federal law restricts this device to sale, distribution, and use by or on the order of a physician," to that specified in 21 CFR 801.109(b)(1), "Caution: Federal law restricts this device to sale by or on the order of a physician". FDA also acknowledges and approves the substitution of "(USA)" for "Federal law" for devices distributed outside of the United States.
P860005/S009 4/28/98	Pro Osteon® Implant 500 Porous Hydroxyapatite Bone Graft Substitute Blocks and Granules	Interpore International Irvine, CA 92618-2402	Approval for several labeling changes as identified and agreed upon in an April 17, 1998 facsimile of the labeling. The device name will also be modified and will be marketed under the trade name "Pro Osteon® Implant 500 Porous Hydroxyapatite Bone Graft Substitute Blocks and Granules." The device is indicated for the repair of metaphyseal fracture defects and long bone cyst and tumor defects. For metaphyseal fracture defects, the device is indicated for treatment which occurs within one month of fracture. The device is to be used in conjunction with rigid internal fixation as dictated by the clinical use requirements in skeletally mature individuals.
P860019/S137 4/15/98	SCIMED® REBEL™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	SCIMED Life Systems, Inc. Maple Grove, MN 55311	Approval for placement of additional marker bands on the 20 mm and 30 mm SCIMED REBEL PTCA Catheters.
P860019/S138* 4/6/98	SCIMED® NC RANGER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for additional balloon lengths of 16 mm and 18 mm with balloon sizes of 1 mm up to 4.0 mm in Ľ mm increments for the SCIMED® NC Ranger™ PTCA Catheter.
P880091/S012 4/17/98	ELASTIMIDE™ Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses	Staar Surgical Company Monorovia, CA 91016	Approval for parametric release of lenses sterilized in the previously approved sterilizer.
P910066/S007 4/3/98	Orthologic 1000 and 1000cc Bone Growth Stimulators	Orthologic Corporation Phoenix, AZ 85034	Approval for a manufacturing site located at Orthologic Corp., 1275 W. Washington Street, Temple, AZ.
P920047/S009 4/6/98	EPT-1000 Cardiac Ablation System	EP Technologies San Jose, CA 95134-2012	Approval for design modifications that provide for new circuitry to an accessory of the system (Automatic Personality Module) which permits filtering of electrograms during ablation.
P930029/S011 4/20/98	Atakr Radiofrequency Catheter Ablation System	Medtronic Cardio Rhythm Sunnyvale, CA 94089-1113	Approval for a manufacturing site located at Medtronic Milaca, 900 Sixth Ave., NE, Milaca, MN 56353 (ERN 2183613).
P940031/S011 4/30/98	Vigor® DR/SR Pacemaker System	Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798	Approval for the addition of the MERIDIAN™ and DISCOVER™ Pacemaker Systems to the current VIGOR family of pacemakers. The device, as modified, will be marketed under trade name MERIDIAN™ and DISCOVER™ Pacemaker Systems and generally indicated for long-term cardiac pacing. Generally accepted indications for long-term cardiac pacing include, but are not limited to, sick sinus syndrome; chronic sinus arrhythmias, including sinus bradycardia, sinus arrest, and sinoatrial (SA) block; second-and third-degree atrioventricular (AV) block; bradycardia-tachycardia syndrome; and carotid sinus syndrome. Patients who demonstrate hemodynamic improvement from atrioventricular synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicated for treatment of atrioventricular synchrony, including varying degrees of AV block; low cardiac output or congestive heart failure related to bradycardia; and certain tachyarrhythmias. The adaptive-rate pacing modes of the pacemaker are indicated for patients exhibiting chronotropic incompetence and who would benefit by increased pacing rates concurrent with elevated metabolic demand.
P950001/S003 4/8/98	Selute® Picotip™ Steroid Eluting, Endocardial Pacing Leads Models 4030, 4031, 4032, 4033, 4034, and 4035	Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798	Approval for: a) Selute® Picotip™ Steroid Eluting, Endocardial Pacing Lead Model 4030, 4031, 4032, 4033, 4034, and 4035 which are indicated for chronic pacing and assessing of the ventricle when used with a compatible pulse generator, and b) the use of the Cosmed of Illinois facility as an alternate sterilization site.
P960043/S006 4/6/98	Techstar® XL and Prostar® XL Percutaneous Vascular Surgical (PVS) Systems	Perclose, Inc. Menlo Park, CA 94025	Approval for changes to the PVS patient guide and post-procedure (nursing) guide.
P960047/S001 4/2/98	Osteonics® Constrained Acetabular Insert	Osteonics Corporation Allendale, NJ 07401-1677	Approval for: 1) The introduction of 10 additional sizes to the PMA-approved constrained acetabular insert product line; 2) A minor modification in the packaging scheme applicable to the PMA-approved constrained acetabular insert product line; 3) Manufacturing tolerance changes to the PMA-approved constrained acetabular insert product line; and 4) An inspection code modification on the engineering drawing for the PMA- approved constrained acetabular insert product line. The device, as modified, will be marketed under the trade name Osteonics Constrained Acetabular Insert and is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
P970052/S001 4/8/98	LYNX™ Contour Balloon Coronary Dilatation Catheter	CardioVascular Dynamics, Inc. Irvine, CA 92618	This catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

*Evaluated as a "Real-Time Review" PMA Supplement.

30-DAY NOTICES

N/A

SUMMARY STATISTICS FOR PMA ORIGINALS & SUPPLEMENTS

Summary of PMA Originals & Supplements Approved

Originals: 4
Supplements: 14

Summary of PMA Originals Under Review

Total Under Review: 75
Total Active: 41
Total On Hold: 34
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review

Total Under Review: 252
Total Active: 173
Total On Hold: 79
Number Greater Than 180 Days: 7

Summary of All PMA Submissions Received

Originals: 5
Supplements: 40

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 14
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 130.7
Number Greater Than 180 Days: 5

Updated 5/26/1998

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Center for Devices and Radiological Health / CDRH