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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 HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Supplement NumberS019
Date Received10/18/2010
Decision Date05/17/2011
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INTRODUCTION OF A NEW HEMOSTATIC MATRIX FORMULATION, REDESIGN OF THE APPLICATION COMPONENTS, REORGANIZATION OF THE PACKAGING, AND ADDITION OF EVITHROM LYOPHILIZED THROMBIN LABELING DIRECTLY INTO THE DIRECTIONS FOR USE AS WELL AS OTHER UPDATED LABELING CHANGES.
Approval OrderApproval Order
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