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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceFLOSEAL MATRIX/PROCEED HEMOSTATIC SEALANTS
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
BAXTER HEALTHCARE CORP.
32650 n wilson rd
round lake, IL 60073
PMA NumberP990009
Supplement NumberS010
Date Received08/31/2001
Decision Date02/06/2002
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the removal of the urological exclusion from the intended use statement.
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