Medical Devices; Reclassification and Codification of the Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture
fda-device · Food and Drug Administration · Rule · Published 2000-04-18 · Effective 2000-05-18 · 65 FR 20734
Document
Document number
00-9577
Federal Register citation
65 FR 20734
CFR reference
21 CFR 878
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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).