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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 NumberS004
Date Received06/21/2024
Decision Date07/18/2024
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for a change to the existing PerClot Dichloroacetate (‘DCA’) test methodology to allow for a detection limit of DCA residuals
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