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This article was originally published in The Gray Sheet
FDA approves Sept. 14, 1994 petition by W.L. Gore and Associates to reclassify nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical sutures for soft tissue approximation and ligation from Class III to Class II, effective May 18. As a special control, the device is labeled for "single use only" and contraindicated for ophthalmic and neural tissues, according to an April 18 Federal Register notice
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