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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 NumberS002
Date Received12/29/2025
Decision Date06/25/2026
Product Code SGV 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT04819945
Supplement TypePanel Track
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 the ETHIZIA Hemostatic Patch for expanding the indications to include minimally invasive surgical procedures on the liver.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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