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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 5 ML/10 ML KIT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
32650 N WILSON RD
ROUND LAKE, IL 60073
PMA NumberP990009
Supplement NumberS025
Date Received02/26/2009
Decision Date01/07/2010
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR INCLUSION OF HUMAN THROMBIN THAT HAS BEEN TREATED WITH A SECOND VIRAL INACTIVATION STEP (SOLVENT DETERGENT PROCESS) IN THE FLOSEAL HEMOSTATIC MATRIX KIT AS WELL AS APPROVAL FOR ASSOCIATED LABELING CHANGES TO REFLECT THE ADDITIONAL VIRAL INACTIVATION STEP FOR THE THROMBIN COMPONENT.
Approval OrderApproval Order
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