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:
Summaries of safety and effectiveness are available on the Internet at https://www.fda.gov/cdrh/pmapage.html. Copies of summaries of safety and effectiveness are also available by submitting a written request 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 in the
SUPPLEMENTARY INFORMATION
section of this document when submitting a written request.
FOR FURTHER INFORMATION CONTACT:
Kathy M. Poneleit, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
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 Internet home page at https://www.fda.gov; 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)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(3)), 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 January 1, 2000, through March 31, 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.
Table
1.—
List of Safety and Effectiveness Summaries for Approved PMA's Made Available January 1, 2000, through March 31, 2000
PMA Number/Docket No.
Applicant
Trade Name
Approval Date
P970005/00M-0811
Kremer Laser Eye Center
Kremer Exciber Laser System (Serial #KEA940202)
July 30, 1998
P970055/00M-1215
Biotrin International, Ltd.
Biotrin Parvovirus IgM EIA (V619IMUS)
August 6, 1999
P970054/00M-1216
Biotrin International, Ltd.
Biotrin Parvovirus IgG EIA (V519IGUS)
August 6, 1999
P980049/00M-0915
ELA Medical, Inc.
Defender II Model 9201 Implantable Cardiovascular Defibrillator
September 15, 1999
H990003/99M-4619
American Medical Systems
ActiconTM
Neosphincter
September 20, 1999
( printed page 36818)
P850022(S9)/00M-0901
Biolectron Inc.
SpinalPak® Stimulator
September 24, 1999
H990005/99M-4763
Nitinol Medical Technologies
CardioSEAL® Septal Occlusion System
September 28, 1999
P930034(S12)/00M-0424
Summit Technology
SVS Apex Plus Excimer Laser Workstation w/the Emphasis Discs
October 21, 1999
P910066(S11)/00M-1073
Orthologic Corp.
OrthologicTM
1000 Bone Growth Stimulator
December 17, 1999
P990035/00M-0577
Sunlight Ultrasound Technologies, Ltd.
The SunlightTM
Omnisense Ultrasound Bone Sonometer