# Gastroenterology and Urology Devices; Effective Date of the Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device; Correction
> **Food and Drug Administration** · Final rule; correction. · Published 2000-10-30 · 65 FR 64619
## Document
- **Document number:** 00-27736
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 64619
- **CFR reference:** 21 CFR 876
- **Publication date:** 2000-10-30
- **HHS docket:** Docket No. 94N-0380
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/10/30/00-27736/gastroenterology-and-urology-devices-effective-date-of-the-requirement-for-premarket-approval-of-the)
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