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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.
 
DeviceETHIZIA™ Hemostatic Patch
Generic NameAgent, absorbable hemostatic, collagen with polymeric additives
Regulation Number878.4490
ApplicantETHICON, Inc.
1000 Rte. 202
Raritan, NJ 08869
PMA NumberP240035
Supplement NumberS004
Date Received01/30/2026
Decision Date08/27/2026
Product Code SGV 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at Herotran E-Beam Service GmbH, sterilizer, Guardianstr. 6-10, Bitterfeld-Wolfen, DE
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