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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 NumberS063
Date Received07/31/2019
Decision Date10/24/2019
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for packaging changes related to the automated process change from manual to automated foiling and cartoning at the Ethicon SARL, Neuchatel Switzerland site. In addition, Ethicon will harmonize SURGICEL NU-KNIT and SURGICEL® Original packaging components.
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