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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 NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
32650 N WILSON RD
ROUND LAKE, IL 60073
PMA NumberP990009
Supplement NumberS013
Date Received11/18/2002
Decision Date03/10/2005
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
Approval Order Statement  
APPROVAL FOR AN ALTERNATE KIT CONFIGURATION THAT CONTAINS A HUMAN THROMBIN COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL HEMOSTATIC MATRIX AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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