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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namesuture, surgical, absorbable, polydioxanone
Generic Namesuture, absorbable, synthetic, polyglycolic acid
Regulation Number878.4840
ApplicantETHICON, INC.
PMA NumberN18331
Supplement NumberS018
Date Received02/05/1987
Decision Date06/18/1987
Product Code
NEW[ Registered Establishments with NEW ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No