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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.
 
DeviceFloseal Hemostatic Matrix
Generic NameAbsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
ApplicantBaxter Healthcare Corp
32650 N. Wilson Rd.
Round Lake, IL 60073
PMA NumberP990009
Supplement NumberS058
Date Received11/22/2019
Decision Date08/07/2020
Product Code PMX 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the removal of the lower limit for the syringe extrusion force as a lot-release specification for the 5mL and 10mL configurations of the Floseal Hemostatic Matrix (Floseal).
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