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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 NameFUSION MATRIX-DRY
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namegelatin matrix hemostatic sealant
Regulation Number878.4490
ApplicantFUSION MEDICAL TECHNOLOGIES, INC.
PMA NumberP990009
Supplement NumberS008
Date Received06/18/2001
Decision Date07/20/2001
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing facility located at fusion medical technologies, inc. , fremont, california.
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