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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.
 
DeviceINFUSE BONE GRAFT
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000054
Supplement NumberS004
Date Received01/26/2005
Decision Date04/20/2005
Product Code MPW 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR TWO CHANGES TO THE PROCESSING OF THE RHBMP-2 COMPONENT OF THE DEVICE - THE USE OF A NEW WORKING CELL BANK AND THE USE OF A LONGER HOLD-TIME (<=120 HOURS AT 2-8 DEGREES C COMPARED TO THE CURRENT 24 HOURS) FOR THE MATREX CELLUFINE SULFATE COLUMN.
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