# Medical Devices; Reclassification and Codification of the Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture
> **Food and Drug Administration** · Final rule. · Published 2000-04-18 · Effective 2000-05-18 · 65 FR 20734
## Document
- **Document number:** 00-9577
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 20734
- **CFR reference:** 21 CFR 878
- **Publication date:** 2000-04-18
- **Effective date:** 2000-05-18
- **HHS docket:** Docket No. 94P-0347
## Abstract

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to W. L. Gore and Associates, Inc., reclassifying the nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture intended for use in soft tissue approximation and ligation, including cardiovascular surgery, from class III (premarket approval) to class II (special controls). Accordingly, the order is being codified in the Code of Federal Regulations (CFR).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/04/18/00-9577/medical-devices-reclassification-and-codification-of-the-nonabsorbable-expanded)
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