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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
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Supplement NumberS023
Date Received10/22/2012
Decision Date01/09/2013
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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