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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 SUTURES
Generic NameSuture, nonabsorbable, silk
Regulation Number878.5030
ApplicantLukens Corp.
51 Chubb Way
Somerville, NJ 08876
PMA NumberN80989
Supplement NumberS001
Date Received03/06/1987
Decision Date04/24/1987
Product Code GAP 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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