[Federal Register Volume 65, Number 62 (Thursday, March 30, 2000)]
[Notices]
[Pages 16921-16922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7780]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 99M-4361, 99M-4277, 99M-4693, 99M-4278, 99M-4276, 99M-
4281, 99M-4331, 99M-4279, 99M-4280, 99M-4776, 00M-0578, 99M-4330, 99M-
4810, 99M-4692, 99M-5135, 99M-5327, and 99M-5539]
Medical Devices; Availability of Safety and Effectiveness
Summaries for PMA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket application (PMA) approvals. 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 http://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 Secs. 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 Secs. 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 on the Internet at http://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 Sec. 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 October 1, 1999, through
December 31, 1999. 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.
[[Page 16922]]
Table 1.--List of Safety and Effectiveness Summaries for Approved PMA's
Made Available October 1, 1999, Through December 31, 1999
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PMA Number/Docket
No. Applicant Trade Name Approval Date
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P970010/99M-4361 Synthes (USA) Norian Skeletal December 23,
Repair System 1998
(SRS)
Cancellous Bone
Cement
P970015/99M-4277 Sofamor Danek Inter Fix May 14, 1999
Threaded Fusion
Device
P960033/99M-4693 Staar Surgical StaarviscTM July 2, 1999
Sodium
Hyaluronate
P980053/99M-4278 Advanced Durasphere September 13,
Uroscience, Inc. Injectable 1999
Bulking Agent
P990008/99M-4276 Cook, Inc. Cook MBC PTCA September 27,
Balloon 1999
Dilatation
Catheter
P990001/99M-4281 Vitatron, Inc. Diva Platform September 27,
Implantable 1999
Pulse
Generators &
Pro Vit
Application
Software
Version 3.3.2
P990020/99M-4331 Medtronic Aneurx Aneurx Stent September 28,
Graft System 1999
P980043/99M-4279 Medtronic, Inc. Hancock II September 28,
Bioprosthetic 1999
Heart Valve
P990017/99M-4280 Guidant Cardiac & EVT Abdominal September 28,
Vascular Surgery Aortic Tube/EVT 1999
Abdominal
Aortic
Bifurcated EGS
System
P990004/99M-4776 Ethicon, Inc. Surgifoam September 30,
Absorbable 1999
Gelatin Sponge,
USP
P940034 (S008)/ Gen-Probe, Inc. Gen- September 30,
99M-4782 Probe 1999
Amplified
Mycobacterium
Tuberculosis
Direct Test
(MTD Test)
P990002/99M-4330 Rochester Medical Femsoft Urethral September 30,
Corp. Insert 1999
H980007/99M-4810 Shelhigh, Inc. Shelhigh September 30,
Pulmonic Valve 1999
Conduit Model
NR-4000 with
``No-
React
'' Treatment
P990033/99M-4692 Ceramed Corp. PepGen P-15 October 25, 1999
P990014/99M-5135 Bausch & Lomb Hydroview November 12,
Surgical, Inc. Composite 1999
Hydrogel
Foldable UV-
Absorbing
Posterior
Chamber
Intraocular
Lens
H990007/99M-5327 CryoLife, Inc. BioGlue Surgical
Adhesive
H980006/99M-5539 MDS Nordion, Inc. TheraSphere