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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 NumberS023
Date Received10/22/2012
Decision Date01/09/2013
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the location of the ferrosan medical devices a/s (femd) testing laboratory in soeborg, denmark.
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