Medical devices; reclassification and codification of absorbable poly(glycolide/L-lactide) surgical suture--FDA. Final rule.
The Food and Drug Administration (FDA) is announcing the reclassification and codification of the absorbable poly(glycolide/L-lactide) surgical suture (PGL suture). FDA issued an order in the form of a letter to the manufacturer reclassifying the PGL suture from class III into class II.
D007221:Industry / Q000331:legislation & jurisprudence; D011098:Polyglactin 910 / Q000145:classification / Q000592:standards*; D013523:Surgical Equipment / Q000592:standards*; D013537:Sutures / Q000145:classification / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
D011098:Polyglactin 910