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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 NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
32650 N WILSON RD
ROUND LAKE, IL 60073
PMA NumberP990009
Supplement NumberS007
Date Received03/05/2001
Decision Date04/10/2001
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" FOR FLOSEAL MATRIX(R) HEMOSTATIC SEALANT.
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