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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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
Date Received10/25/2021
Decision Date05/19/2023
Product Code LMG 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02359994
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the PerClot® Absorbable Hemostatic Powder. The device is indicated in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of suture line bleeding or capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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