[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
------------------------------------------------------------------------
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