[Federal Register: October 30, 2000 (Volume 65, Number 210)]
[Rules and Regulations]               
[Page 64619]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30oc00-11]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 94N-0380]

 
Gastroenterology and Urology Devices; Effective Date of the 
Requirement for Premarket Approval of the Implanted Mechanical/
Hydraulic Urinary Continence Device; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of September 26, 2000 (65 FR 
57726). The final rule requires the filing of a premarket approval 
application or a notice of completion of a product development protocol 
for the implanted mechanical/hydraulic urinary continence device, a 
generic type of medical device intended for the treatment of urinary 
incontinence. In the final rule, the effective date was stated 
incorrectly. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Nicole L. Wolanski, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION: In FR Doc. 00-24632 appearing on page 57726 
in the Federal Register of September 26, 2000, the following correction 
is made:
    1. On page 57726, in the second column, under the EFFECTIVE DATE 
caption, the date ``October 26, 2000'' is corrected to read ``September 
26, 2000.''

    Dated: October 19, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-27736 Filed 10-27-00; 8:45 am]
BILLING CODE 4160-01-F