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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Supplement NumberS010
Date Received08/30/2006
Decision Date10/03/2006
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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