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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 AGENT FLOSEAL ENDOSCOPIC APPLICATOR
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
32650 N WILSON RD
ROUND LAKE, IL 60073
PMA NumberP990009
Supplement NumberS016
Date Received11/15/2004
Decision Date03/31/2005
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE ENDOSCOPIC APPLICATOR AND A MODIFICATION OF THE "INDICATION FOR USE" FOR THE ENDOSCOPIC APPLICATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL ENDOSCOPIC APPLICATOR AND IS INDICATED FOR USE IN DELIVERING FLOSEAL MATRIX HEMOSTATIC SEALANT TO BLEEDING SURGICAL SITES THROUGH A 5 MM OR LARGER TROCAR.
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