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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.


Final rule; correction.


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.

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

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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.”

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Dated: October 19, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center for Devices and Radiological Health.

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[FR Doc. 00-27736 Filed 10-27-00; 8:45 am]