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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NamePROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S
Classification Namesuture, nonabsorbable, synthetic, polyethylene
Generic Namesuture, nonabsorbable, synthetic, polyethylene
Regulation Number878.5000
ApplicantETHICON, INC.
PMA NumberN16374
Supplement NumberS032
Date Received02/05/1987
Decision Date06/18/1987
Product Code
GAT[ Registered Establishments with GAT ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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