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

---
identifier: "/us/fr/00-27736"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Gastroenterology and Urology Devices; Effective Date of the Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "00-27736"
section_name: "Gastroenterology and Urology Devices; Effective Date of the Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device; Correction"
positive_law: false
currency: "2000-10-30"
last_updated: "2000-10-30"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "00-27736"
document_type: "rule"
publication_date: "2000-10-30"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 876"
fr_citation: "65 FR 64619"
fr_volume: 65
docket_ids:
  - "Docket No. 94N-0380"
fr_action: "Final rule; correction."
---


#  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.

**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.