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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 Place
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS017
Date Received02/22/2005
Decision Date03/11/2005
Product Code NEK 
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 USE OF NEW SHIPPING CONTAINER. THE NEW CONTAINER IS LIGHTER THAN THE CURRENT CONTAINER AND USES POLYSTYRENE INSULATION INSTEAD OF POLYURETHANE.
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