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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 MATRIX HEMOSTATIC SEALANT
Generic NameAbsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
32650 N WILSON RD
ROUND LAKE, IL 60073
PMA NumberP990009
Supplement NumberS045
Date Received12/05/2016
Decision Date01/04/2017
Product Code PMX 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for modification to the Instructions for Use to add clarity that the removal of excess product is done to avoid excessive inflammatory reaction, adhesion and/or granuloma formation.
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