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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 NumberS009
Date Received12/20/1982
Decision Date05/02/1984
Product Code
GAM[ Registered Establishments with GAM ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No