Medical devices; reclassification and codification of the nonabsorbable expanded polytetrafluoroethylene surgical suture.  Food and Drug Administration, HHS. Final rule.
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).
D018795:Device Approval; D006801:Humans; D013537:Sutures / Q000145:classification* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration