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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.
 
DeviceSURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic Matrix Kit with Thrombin
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Supplement NumberS066
Date Received04/05/2024
Decision Date05/02/2024
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  
using molding tool for the luer lock of syringes for the SURGIFLO® Hemostatic Matrix and SURGIFLO® Hemostatic Matrix Kit with Thrombin
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