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Zdrowie i gospodarka · 19/12/2002

FDA Reclassifies Ethicon's PDS Suture from Class III to Class II

The FDA has reclassified Ethicon's absorbable polydioxanone surgical suture, PDS, from a Class III device requiring premarket approval to a Class II device with special controls, effective immediately, following new information submitted by the manufacturer.

Source: Federal Register — Food and Drug AdministrationOpen original release →