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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namesuture, nonabsorbable, synthetic, polyester
Generic Namesuture, nonabsorbable, synthetic, polyester
Regulation Number878.5000
ApplicantETHICON, INC.
PMA NumberN17804
Supplement NumberS035
Date Received10/28/1986
Decision Date12/03/1986
Product Code
GAS[ Registered Establishments with GAS ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No