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

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.

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