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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(R) MATRIX/PROCEED(TM) HEMOSTATIC SEALANT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namegelatin matrix hemostatic sealant
Regulation Number878.4490
ApplicantFUSION MEDICAL TECHNOLOGIES, INC.
PMA NumberP990009
Supplement NumberS005
Date Received02/01/2001
Decision Date03/15/2001
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification kit configuration without the thrombin component.
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