Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMA's) that have been approved. This list is intended to inform the public of the...
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMA's) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMA's through the Internet and the agency's Dockets Management Branch.
ADDRESSES:
Submit a written request for copies of summaries of safety and effectiveness to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION
section for electronic access to the summary of safety and effectiveness
FOR FURTHER INFORMATION CONTACT:
Thinh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I. Background
In the
Federal Register
of January 30, 1998 (63 FR 4571), FDA published a final rule to revise §§ 814.44(d) and 814.45(d) (21 CFR 814.44(d) and 814.45(d)) to discontinue publication of individual PMA approvals and denials in the
Federal Register
. Instead, revised §§ 814.44(d) and 814.45(d) state that FDA will notify the public of PMA approvals and denials by posting them on FDA's home page at http://www.fda.gov on the Internet; by placing the summaries of safety and effectiveness on the Internet and in FDA's Dockets Management Branch; and by publishing in the
Federal Register
after each quarter a list of available safety and effectiveness summaries of approved PMA's and denials announced in that quarter.
FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the
Federal Register
, and FDA believes that the Internet is accessible to more people than the
Federal Register
.
In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision.
The following is a list of approved PMA's for which summaries of safety and effectiveness were placed on the Internet in accordance with the procedure explained previously from July 1, 2000, through September 30, 2000. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date.
( printed page 78496)
Table
1.—
List of Safety and Effectiveness Summaries for Approved PMA's Made Available July 1, 2000, Through September 30, 2000
PMA Number/Docket No.
Applicant
Trade Name
Approval Date
P930016(S7)/00M-1391
VISX, Inc.
VISX STAR S2 Excimer Laser System
November 2, 1998
P920030(S2)/00M-1536
Chiron Corp.
CIBA Corning ACS PSA Immunoassay
December 8, 1998
P910065(S1)/00M-1523
Tosoh Medics, Inc.
AIA-PACK PA
September 10, 1999
P990010/00M-1447
CRS Clinical Research, Inc.
VISX Inc. Excimer Laser System Model C “STAR”
November 19, 1999
P940035(S2)/00M-1522
Matritech Inc.
Matritech NMP22® Test Kit
January 18, 2000
P990023/00M-0809
Alcon Laboratories
Cellugel® Ophthalmic Viscosurgical Device
February 24, 2000
P990054/00M-1517
Cardiac Pathways Corp.
Chilli® Cooled Ablation System
March 17, 2000
H990014/00M-1451
Medtronic Inc.
EnterraTM
Therapy System (formerly named Gastric Electrical Stimulation (GES) System)
March 31, 2000
P990053/00M-1448
Nellcor Puritan Bennett
OxiFirst® Fetal Oxygen Saturation Monitoring System
May 12, 2000
P990028/00M-1507
Focal, Inc.
Focal Seal-L Synthetic Absorbable Sealant
May 26, 2000
P980050/00M-1389
Medtronic Inc.
Medtronic® Jewel® AF 7250 Dual Chamber Implantable Cardioverter Defibrillator
June 14, 2000
P990025/00M-1388
Biosense Webster, Inc.
NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter
June 15, 2000
P950032(S16)/00M-1508
Organogenesis, Inc.
Apligraf (Graftskin)
June 20, 2000
P99037/00M-1390
Vascular Solutions, Inc.
Vascular Solutions Duett Sealing Device
June 22, 2000
P990078/00M-1386
Sunrise Technologies
Hyperion LTK System
June 30, 2000
P990021/00M-1387
QLT Photo Therapeutics, Inc.
Diomed 630 PDT Laser, Model T2USA
June 30, 2000
P990018/00M-1414
Menicon USA, Inc.
MeniconTM
Z Rigid Gas Permeable Contact Lens
July 11, 2000
P000006/00M-1415
Mentor Corp.
Alpha 1 Inflatable Penile Prosthesis
July 14, 2000
P990064/00M-1416
Medtronic Inc.
Mosaic® Porcine Bioprosthesic Heart Valve
July 14, 2000
P990034/00M-1495
Medtronic Inc.
Medtronic® IsoMed® Constant Flow Infusion System
July 21, 2000
P990039/00M-1437
Metra Biosystems, Inc.
QUS-2TM
Calcaneal Ultrasonometer
August 1, 2000
P990072/00M-1475
Westcon Contact Lens Co., Inc.
W-55 (Methafilcon A) and Horizon 55 Soft Extended Wear Contact Lenses