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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.
 
Trade NameFLOSEAL MATRIX HEMOSTATIC SEALANT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namegelatin matrix hemostatic sealant
Regulation Number878.4490
ApplicantFUSION MEDICAL TECHNOLOGIES, INC.
PMA NumberP990009
Supplement NumberS007
Date Received03/05/2001
Decision Date04/10/2001
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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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