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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™ Original Absorbable Hemostat, SURGICEL™ NU-KNIT Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantETHICON, Inc.
1000 Rte. 202
Raritan, NJ 08869
PMA NumberN12159
Supplement NumberS086
Date Received09/07/2021
Decision Date07/26/2022
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling changes for SURGICEL Original Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SURGICEL SNoW Absorbable Hemostat, including bacteria nomenclature updates and addition of verbiage to bactericidal information, addition of U.S.P statement for oxidized regenerated cellulose, and addition of MRI safety claim.
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