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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.
 
DeviceSURGICEL Absorbable Hemostats
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantETHICON, Inc.
1000 Rte. 202
Raritan, NJ 08869
PMA NumberN12159
Supplement NumberS076
Date Received10/15/2020
Decision Date11/12/2020
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of SURGICEL Original and NU-KNIT Absorbable Hemostats Extra Small (XS) and NU-KNIT Medium (M) sized foil pouches to the upgraded Final Seal Inspection System on the automated Foiling Line (G11719) at the Ethicon SARL, Switzerland site for the inspection of hermetically sealed foil pouches.
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