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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
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Supplement NumberS028
Date Received03/06/2015
Decision Date02/05/2016
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for a manufacturing site located at SteriPack Medical Poland SP.ZO.O., Poland, for the contract packaging of the SURGIFLO Hemostatic Matrix Device and thesterilizing site located at Synergy Health Ede BV, Netherlands, for the sterilization of theSURGIFLO Hemostatic
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