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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.
 
DevicePerClot® Polysaccharide Hemostatic System
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantBaxter Healthcare Corporation
25212 W. Illinois Rte. 120
Round Lake, IL 60073
PMA NumberP210036
Supplement NumberS007
Date Received12/23/2025
Decision Date06/08/2026
Product Code LMG 
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 the transfer of production of the PerClot Absorbable Hemostatic Powder to an alternate manufacturing site, Beijing Huan Qiu Li Kang Biotech Co., Ltd., (HQLK) in Beijing, China.
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