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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, U.S.P., Dental Sponge, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidect
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Supplement NumberS051
Date Received11/22/2021
Decision Date12/21/2021
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to the Electron beam (E-beam) equipment located at the current E-beam contract sterilization site for the SURGIFOAM® Absorbable Gelatin Dental Sponge, the SURGIFOAM® Absorbable Gelatin Hemorrhoidectomy Sponge, and the SURGIFOAM® Absorbable Gelatin Powder.
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