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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, U.S.P
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable gelatin sponge, usp
Regulation Number878.4490
ApplicantETHICON, INC.
PMA NumberP990004
Supplement NumberS007
Date Received11/16/2004
Decision Date01/07/2005
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new sterilization site located at isotron plc, swindon, united kingdom.
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