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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 Route 120
Round Lake, IL 60073
PMA NumberP210036
Supplement NumberS001
Date Received10/31/2023
Decision Date05/08/2024
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change in the equipment utilized for granularity testing for PerClot Polysaccharide Hemostatic System
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