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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePDS(TM) SUTURE (CLEAR)
Generic NameSuture, absorbable, synthetic, polyglycolic acid
Regulation Number878.4493
ApplicantETHICON, Inc.
P.O Box 151, Rte. 22 W.
Somerville, NJ 08876
PMA NumberN18387
Supplement NumberS012
Date Received02/09/1987
Decision Date06/18/1987
Product Code GAM 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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