[Federal Register: November 21, 2000 (Volume 65, Number 225)]
[Notices]               
[Page 69941-69942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no00-91]                         

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical 
Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 4, 2000, 10 
a.m. to 6 p.m., and December 5, 2000, 8 a.m. to 2 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Megan Moynahan, Center for Devices and Radiological 
Health (HFZ 450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8517, ext. 171, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12625. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On December 4, 2000, the committee will discuss and make 
recommendations on a reclassification petition proposing to down-
classify percutaneous transluminal coronary angioplasty (PTCA) 
catheters from class III to class II. The petition is available for 
public review and comment on the FDA Dockets Management Branch website 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets and is listed as docket number 00P-1533. 
In the context of the reclassification petition, the committee will be 
asked to consider possible modifications to the draft guidance document 
entitled ``Guidance for the Submission of Research and Marketing 
Applications for Interventional Cardiology Devices: PTCA Catheters, 
Atherectomy Catheters, Lasers, Intravascular Stents'' (May 1995). The 
guidance document can be viewed on the FDA website at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ode/846.pdf. Questions for the committee regarding the December 4, 
2000, session can be found on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html.
    On December 5, 2000, the committee will discuss, make 
recommendations, and vote on a premarket approval application for an 
implantable cardioverter defibrillator used in the treatment of atrial 
fibrillation.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by November 27, 
2000. Oral presentations from the public will be scheduled between 
approximately 10 a.m. and 10:30 a.m., and near the end of the committee 
deliberations on December 4, 2000; and between approximately 8 a.m. and 
8:30 a.m., and near the end of the committee deliberations on December 
5, 2000. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before November 27, 2000, and submit a brief statement of the 
general nature of the evidence or arguments they wish to present, the 
names and addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).


[[Page 69942]]


    Dated: November 15, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-29668 Filed 11-20-00; 8:45 am]
BILLING CODE 4160-01-F