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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/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS009
Date Received04/20/2004
Decision Date04/20/2005
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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