§ 878.4493. Absorbable poly(glycolide/l-lactide) surgical suture.
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/us/cfr/t21/s§ 878.4493·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.
(b)Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document. [56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003]
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§ 878.4493
Absorbable poly(glycolide/l-lactide) surgical suture.
Fed. Reg.×1
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