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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 NameSURGIFOAM HEMOSTATIC MATRIX KIT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable gelatin sponge, usp
Regulation Number878.4490
ApplicantFERROSAN MEDICAL DEVICES A/S
PMA NumberP990004
Supplement NumberS017
Date Received03/08/2010
Decision Date05/31/2011
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the reconstitution of method for the thrombin component and modified the method of mixing with the powdered gelatin component.
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