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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, USP, ORAL SPONGE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable gelatin sponge, usp
Regulation Number878.4490
ApplicantETHICON LTD.
PMA NumberP990004
Supplement NumberS010
Date Received08/30/2006
Decision Date10/03/2006
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an oral surgery form of surgifoam absorbable gelatin sponge, usp. The device, as modified, will be marketed under the trade name surgifoam absorbable gelatin sponge, usp, oral sponge and is indicated for use as an adjunct to hemostasis during surgical procedures.
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