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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 NumberS122
Date Received08/07/2025
Decision Date11/04/2025
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for qualification of the use of the SURGICEL™ FIBRILLAR (hereafter called as Surgicel Fibrillar) material to produce SURGICEL™ Powder Absorbable Haemostatic Powder (hereafter called as Surgicel Powder) manufacturing at Ethicon, LLC, San Lorenzo, Puerto Rico facility.
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