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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
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Supplement NumberS001
Date Received11/15/1999
Decision Date12/02/1999
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 the addition of sponges 3mm and 7mm thick.
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