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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namesuture, absorbable, synthetic, polyglycolic acid
Generic Namesuture, synthetic absorbable surgical, polydioxano
Regulation Number878.4493
ApplicantETHICON, INC.
PMA NumberN18331
Supplement NumberS011
Date Received03/04/1983
Decision Date04/18/1983
Product Code
GAM[ Registered Establishments with GAM ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No