[Federal Register: January 15, 2002 (Volume 67, Number 10)]
[Notices]               
[Page 1980-1981]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja02-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 01M-0271, 01M-0255, 01M-0210, 01M-0173, 01M-0254, 01M-
0227, 01M-0226, and 01M-0270]

 
Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

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 approval applications (PMAs) that have been approved. This 
list is intended to inform the public of the availability of safety and 
effectiveness summaries of approved PMAs through the Internet and the 
agency's Dockets Management Branch.

ADDRESSES: Submit written requests 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 summaries 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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 PMAs 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 
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 PMAs for which summaries of 
safety

[[Page 1981]]

and effectiveness were placed on the Internet in accordance with the 
procedure explained previously from April 1, 2001, through June 30, 
2001. 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 PMAs Made Available April 1, 2001, Through
                                                  June 30, 2001
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 PMA Number/Docket No.         Applicant                        Trade Name                     Approval Date
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P990086/01M-0271        HealthTronics, Inc.     HealthTronics OssaTron           October 12, 2000
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P000023/01M-0255        TMJ Implants, Inc.      TMJ Fossa-Eminence/Condylar Prosthesis     January 5, 2001
                                                 System\TM\
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P000035/01M-0210        TMJ Implants, Inc.      TMJ Fossa-Eminence Prosthesis\TM\          February 27, 2001
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P990080/01M-0173        Pharmacia & Upjohn Co.  CeeOn\TM\ Edge Foldable Ultraviolet Light- April 5, 2001
                                                 Absorbing Posterior Chamber Intraocular
                                                 Lens, Model 911A
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P980050(S1)/01M-0254    Medtronic, Inc.         Medtronic Model 7350             April 6, 2001
                                                 Jewel AF Implantable
                                                 Cardioverter Defibrillator System,
                                                 Medtronic Model 9465 InCheck\TM\ Patient
                                                 Assistant, and Medtronic
                                                 Transvene CS/SVC Model 6937A
                                                 Lead
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P000046/01M-0227        Anika Therapeutics,     Staar Surgical Co. STAARVISC\TM\ II        April 18, 2001
                         Inc.                    Sodium Hyaluronate
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P000044/01M-0226        Ortho-Clinical          Vitros Immunodiagnostic Products HBsAg     April 27, 2001
                         Diagnostics, Inc.       Reagent Pack, HBsAg Confirmatory Kit,
                                                 and HBsAg Calibrator
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P000037/01M-0270        Medical Carbon          ON-X Prosthetic Heart Valve,     May 30, 2001
                         Research Institute,     Model ONXA
                         LLC.
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II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/pmapage.html.

    Dated: December 31, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-901 Filed 1-14-02; 8:45 am]
BILLING CODE 4160-01-S