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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 ABSORBABLE GELATIN SPONGE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable gelatin sponge, usp
Regulation Number878.4490
ApplicantETHICON, INC.
PMA NumberP990004
Supplement NumberS013
Date Received07/05/2007
Decision Date12/27/2007
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the removal of the urologic procedures exclusion from the indications statement.
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