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PMA Final Decisions Rendered for May 1997 |
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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.
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| P950027 5/28/97 |
Hyalgan® | FIDIA Pharmaceutical Corporation Washington, D.C. 20006 |
This device 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. |
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| N18033/S030 5/14/97 |
ACUVUE® (etafilcon A) Soft (hydrophilic) Extended Wear Contact Lens (Clear and Visibility Tinted, with UV Blocker) | VISTAKON, Johnson-Johnson Vision Products,
Inc. Jacksonville, FL 32247 |
Minor changes in the initiator ratio (increased amount) for the ACUVUE® (etafilcon A) contact lens, which was approved as N18-033/S29 on October 7, 1996. |
| N18331/S027 5/12/97 |
PDS* II (Polydioxanone) Suture, Dyed & Undyed | ETHICON, Inc. Somerville, NJ 08876 |
Approval for use as a component of the Ethicon ENDOSUTURE System and the addition of ETHICON LTD., Scotland, (Ethicon, Ltd., Edinburgh, Scotland and Ethicon, Ltd., West Lothian, Scotland) as a manufacturer of PDS II Suture used in the ETHICON ENDOSUTURE System and for the assembly of the System components. The device, as modified, will be marketed under the trade name ETHICON ENDOSUTURE and is indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. |
| P790019/S009 5/28/97 |
Abbott HAVAB®-M and HAVAB®-M EIA | Abbott Laboratories Abbott Park, IL 60064-3500 |
Approval for a change in the specifications for the Positive Control Sample to Standard ratio from 0.90-1.15 to 0.85-1.15, and a change in the evaluation of the Hepatitis A Virus Solution and the HAVAB®-M EIA Conjugate from a Sample to Standard Ratio to a Sample to Target Ratio. |
| P810046/S170 5/13/97 |
ACS Coronary Dilatation Catheters | Guidance Corporation Advanced
Cardiovascular Systems, Inc. Santa Clara, CA 95052-8167 |
Approval for: a) the addition of the indication "balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction"; and b) other modifications to the current label to reflect this new indication. |
| P810046/S171 5/12/97 |
ACS RX COMET Coronary Dilatation Catheter with 40 mm, quarter-sized/15 mm, 30 mm and 20 mm balloon lengths | Guidant Corporation Advanced
Cardiovascular Systems Santa Clara, CA 95052-8167 |
Approval for the ACS RX COMET Coronary Dilatation Catheter with the 40 mm balloon lengths with the half sizes (i.e., 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm), the 15 mm balloon lengths with the quarter sizes (i.e., 2.75 mm, 3.25 mm and 3.75 mm diameters), the 30 mm balloon lengths (i.e., 2.75 mm, 3.25 mm, 3.75 mm and 4.0 mm diameters) and single 20 mm balloon length (i.e., 1.5 mm) and modification of the balloon compliance chart of the ACS RX Comet Coronary dilatation Catheter to include data up to 18 atm for balloons with a rated burst pressure (RBP) of 14 atm to be consistent with other PTCA manufacturers. |
| P810055/S067 5/28/97 |
Model 777A Ultraviolet-Absorbing Posterior Chamber Intraocular Lens | Pharmacia & Upjohn Company Pickerington, OH 43147 |
Approval for Tier A posterior chamber intraocular lens Model 777A. This intraocular lens is indicated for use in the visual correction of aphakia in patients 60 years of age and older, who are undergoing a primary lens implantation, in either the ciliary sulcus or capsular bag following an extracapsular cataract extraction. |
| P820001/S021 5/15/97 |
OPTI-FREE® SUPRACLENS Daily Protein Remover and OPTI-SOAK® Conditioning Solution | Alcon Laboratories, Inc. Fort Worth, TX 76134-2099 |
Approval for 1) use of OPTI-SOAK® Conditioning Solution as an alternate diluent for OPTI-FREE® SUPRACLENS Daily Protein Remover, 2) to expand the indications for use of OPTI-FREE® SUPRACLENS to allow for use with rigid gas permeable (RGP) contact lenses, and 3) for use of OPTI-CLEAN® II Daily Cleaner as an alternate daily cleaner in the OPTI-SOAK® lens care regimen. |
| P820060/S011 5/16/97 |
Abbott AxSYM AFP | Abbott Laboratories Abbott Park, IL 60064-3537 |
Approval for the addition of a system performed automated dilution protocol for a 1:101 sample dilution of amniotic fluid 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 nonseminomatous 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). Test results when used in conjunction with ultrasonography or amniography are a safe and effective aid in the detection of fetal open NTD. |
| P830037/S040 5/15/97 |
DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Spherical and Optifit® Toric Clear, LiteTint, Colors, and Color Complements Soft (Hydrophilic) Contact Lenses (Lathe Cut) for Extended Wear | Wesley-Jessen Corporation Des Plaines, IL 60018-5903 |
Approval to add an ultra violet absorber to the clear and LiteTint lathe cut polymer rods for the subject devices. The devices, as modified, will be marketed under the trade names DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Spherical and Optifit® Toric Clear, LiteTint, Colors, and Color Complements Soft (Hydrophilic) Contact Lenses (Lathe Cut) for Extended Wear with no change in the currently approved indications for use. |
| P830071/S008 5/15/97 |
OPTI-FREE® SUPRACLENS Daily Protein Remover and OPTI-SOAK® Conditioning Solution | Alcon Laboratories, Inc. Fort Worth, TX 76134-2099 |
Approval for 1) use of OPTI-SOAK® Conditioning Solution as an alternate diluent for OPTI-FREE® SUPRACLENS Daily Protein Remover, 2) to expand the indications for use of OPTI-FREE® SUPRACLENS to allow for use with rigid gas permeable (RGP) contact lenses, and 3) for use of OPTI-CLEAN® II Daily Cleaner as an alternate daily cleaner in the OPTI-SOAK® lens care regimen. |
| P840008/S058 5/5/97 |
Dornier Compact S and the Dornier Lithotripter (Stationary and Transportable) | Dornier Medical Systems, Inc. Kennesaw, GA 30144 |
Approval for a non-ECG shock wave trigger mode for the Dornier Compact S and the Move and Shoot feature for the Dornier Lithotripter (Stationary and Transportable) |
| P840024/S069 5/15/97 |
Nucleus 22 Channel Cochlear Implant System for Children | Cochlear Corporation Englewood, CO 80112 |
Approval for addition of a new sterilization site at Griffith Microscience, Willowbrook, IL |
| P850064/S012 5/16/97 |
Model 203 Life Pulse High Frequency Ventilator |
Bunnell, Inc. Salt Lake City, UT 84115 |
Approval for a labeling change to include an additional warning advising against troubleshooting while the ventilator is in operation. |
| P850077/S023 5/19/97 |
Sunsoft® MULTIPLES (methafilcon A) Soft (Hydrophilic) Contact Lens (Clear and Tinted) | Sunsoft Albuquerque, NM 87109 |
Approval for an alternate molded lens manufacturing process for a multifocal lens design. The device, as modified, will be marketed under the trade name Sunsoft Multiples and is indicated for daily wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lens is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3.00 diopters (D) of add and who exhibit refractive astigmatism of no more than 1.50 D that does not interfere with visual acuity. The lens ranges in spherical power from -20.00D to +10.00D. |
| P860005/S007 5/30/97 |
PRO OSTEON Implant 500 Coralline Hydroxyapatite Bone Void Filler | Interpore International Irvine, CA 92718-2402 |
Approval for a manufacturing site located at SteriGenics, International, Corona, CA. |
| P890023/S005 5/6/97 |
Ocufilcon D Spherical and Toric Extended Wear Contact Lenses | Ocular Sciences/American Hydron Cupertino, CA 95014 |
Approval for the cast molding method for the manufacture of the ocufilcon D 55% hydrophilic contact lens for extended wear at the company's facility located at Santa Isabel Industrial Park, Puerto Rico 00757. |
| P890057/S008 5/2/97 |
Model 3100A High Frequency Oscillatory Ventilator | SensorMedics Critical Care Corporation Yorba Linda, CA 92687 |
Approval for a gas pressure regulator adjuster screw change. |
| P900052/S004 5/23/97 |
Port-A-Cath Epidural Implantable Access System | SIMS Deltec, Inc. St. Paul, MN 55112 |
Change in indications for use to include long-term, repeated access to the epidural space for the delivery of preservative-free morphine sulfate to relieve chronic intractable pain of non-malignant origin. |
| P900056/S020 5/13/97 |
ROTABLATOR® Rotational Angioplasty System | Boston Scientific Corporation Redmond, WA 98052-3376 |
Approval for an additional contract sterilization facility, Sorex Medical, Salt Lake City, Utah. |
| P900060/S014 5/27/97 |
CarboMedics® Prosthetic Heart Valve (CPHV) | Sulzer Carbomedics, Inc. Austin, TX 78752-1793 | Approval for reduction in the incubation period for biological indicators for sterility release to three days. |
| P910023/S024 5/22/97 |
Cadence Tiered Therapy Defibrillator System | Ventritex, Inc. Sunnyvale, CA 94086-6527 |
Approval to use the Patient Manual, "Peace of Mind." |
| P910023/S028 5/29/97 |
Cadence Tiered Therapy Defibrillator System | Ventritex, Inc. Sunnyvale, CA 94086-6527 |
Approval to distribute the Device Notification Update Letter and the crystal data. |
| P910030/S005 5/12/97 |
GR II Coronary Stent | Cook, Inc. Bloomington, IN 47402 |
Approval for a modified version of the original Gianturco-Roubin Coronary Flex Stent. The device, as modified, will be marketed under the trade name GR II Coronary Stent and is indicated for treatment of acute or threatened closure in patient with failed interventional therapy in vessels with reference diameters in the range of 2.1 mm to 4.0 mm. |
| P910056/S006 5/7/97 |
Soflex Models C24UB and C31UB Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses | Chiron Vision Corporation Claremont, CA 91711 | Approval for revised labeling. |
| P910058/S009 5/7/97 |
Chiroflex Models C10UB and C11UB Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses | Chiron Vision Corporation Claremont, CA 91711 | Approval for revised labeling. |
| P910066/S005 5/9/97 |
OrthoLogic® 1000 Bone Growth Stimulator | OrthoLogic Corporation Phoenix, AZ 85034 |
Approval for the use of in vitro, and in vivo data from studies investigating the biological effects of combined magnetic fields on bone healing at the cellular level. |
| P910077/S018 5/6/97 |
VENTAK® PRx® II/III AICD Systems | CPI/Guidant Corporation St. Paul, MN 55112-5798 |
Approval for RhythmLine transtelephonic interrogation system which will provide remote interrogation and data retrieval and ECG monitoring of patients with VENTAK Prx II and PRx III pulse generators. |
| P920014/S006 5/22/97 |
TCI HeartMate® IP LVAS | Thermo Cardiosystems, Inc. Woburn, MA 01888-2697 |
Approval for a change to the interim percutaneous drive line design. |
| P930012/S006 5/29/97 |
The Wrap PTCA Catheter | Progressive Angioplasty Systems, Inc. Menlo Park, CA 94025 |
Approval for the Wrap PTCA Catheter. |
| P930038/S005 5/1/97 |
Angio-Seal Hemostatic Puncture Closure Device | Quinton Instrument Company Bothell, WA 98021-8906 |
Approval for a change to the indications for use for the Angio-Seal device. The Angio-Seal Hemostatic Puncture Closure Device is now indicated for use in closing and in reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography or interventional procedures using a retrograde approach and an 8 French or smaller procedural sheath. |
| P950002/S002 5/9/97 |
BAK Interbody Fusion System Minneapolis, MN 55439-2029 |
Spine-Tech, Inc. Minneapolis, MN 55439-2029 | Additional sizes to the BAK product line: BAK Implants and End Caps. |
Updated 12/7/1998
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