[Federal Register Volume 66, Number 48 (Monday, March 12, 2001)]
[Notices]
[Pages 14390-14391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00M-1640, 00M-1664, 00M-1591, 00M-1613, 00M-1597, 00M-
1593, 00M-1583, 00M-1615, 00M-1612, 00M-1569, 00M-1658, 00M-1570, 00M-
1616, 00M-1659, 00M-1649, 00M-1650, 00M-1660, 00M-1661, 00M-1683, 00M-
1684]


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 (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 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 X. 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 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 
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, 2000, through 
December 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 October 1, 2000, Through December 31, 2000
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 PMA Number/
  Docket No.       Applicant            Trade Name         Approval Date
------------------------------------------------------------------------
P970053/00M-   Nidek             EC-5000 Excimer Laser     December 17,
 1640           Technologies,     System                    1998
                Inc.
P970053(S1)/   Nidek             EC-5000 Excimer Laser     September 29,
 00M-1664       Technologies,     System (PARK)             1999
                Inc.
P930034(S13)/  Summit            SVS Apex Plus Excimer     October 21,
 00M-1591       Technologies      Laser Workstation         1999
P990019/00M-   DUSA              BLU-U Light Photodynamic  December 3,
 1613           Pharmaceuticals   Therapy Illuminator       1999
                , Inc.

[[Page 14391]]

 
P990027/00M-   Bausch & Lomb     Technolas 217   February 23,
 1597           Surgical, Inc.    Excimer Laser System      2000
P970043(S5)/   Autonomous        LADAR Vision    May 9, 2000
 00M-1593       Technologies      Excimer Laser System
                Corp.
P990052/00M-   Symphonix         Vibrant P/Vibrant D       August 31,
 1583           Devices, Inc.     Soundbridge System        2000
P980010/00M-   Osteometer        DTU-One Ultrasound        September 19,
 1615           MediTech, Inc.    Scanner                   2000
P970043(S7)/   Autonomous        LADAR Vision    September 22,
 00M-1612       Technologies      Excimer Laser System      2000
                Corp.
P990040/00M-   Cordis            Trufill N-Butyl           September 25,
 1569           Neurovascular,    Cyanoacrylate Liquid      2000
                Inc.              Embolic System
P000014/00M-   Ortho-Clinical    VITROS Immunodiagnostic   September 29,
 1658           Diagnostics,      Anti-HBS Reagent Pack     1999
                Inc.              and Calibrators
P990046/00M-   ATS Medical,      ATS Open Pivot  October 13,
 1570           Inc.              Bileaflet Heart Valve     2000
N18286(S12)/   Pharmacia &       Gelfoam         October 16,
 00M-1616       Upjohn Co.        Sterile Powder            2000
P000015/00M-   Cochlear Corp.    Nucleus 24 Auditory       October 20,
 1659                             Brainstem Implant (ABI)   2000
                                  System
P000018/00M-   Novoste Corp.     Beta-CathTM System        November 3,
 1649                                                       2000
P990036/00M-   Cordis Corp.      Cordis CheckmateTM        November 3,
 1650                             System                    2000
P990056/00M-   Roche             Elecsys Total   November 22,
 1660           Diagnostics,      PSA Immunoassay and       2000
                Corp.             Calset
P990081/00M-   Ventana Medical   PathwayTM HER 2           November 28,
 1661           Systems, Inc.                               2000
P000027/00M-   Roche             Elecsys Free    December 12,
 1683           Diagnostics       PSA Immunoassay/Calset/   2000
                Corp.             Calcheck
P980020/00M-   Q Care            Q-103 Needle Management   December 21,
 1684           International,    Systems                   2000
                LLC
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II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cdrh/pmapage.html.

    Dated: March 1, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-5954 Filed 3-9-01; 8:45 am]
BILLING CODE 4160-01-F