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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.
 
DeviceSILK SUTURE, NONABSORBABLE SURG. SUTURE, USP
Generic NameSuture, nonabsorbable, silk
Regulation Number878.5030
ApplicantETHICON, Inc.
Rte. 22 W.
Somerville, NJ 08876
PMA NumberN11397
Supplement NumberS028
Date Received02/23/1990
Decision Date03/20/1990
Product Code GAP 
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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