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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 LUMAR 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 NumberS008
Date Received03/19/2004
Decision Date04/16/2004
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL OF THE ELIMINATION OF THE REAMING STEP IN THE SURGICAL IMPLANTATION PROCEDURES FOR THE LT CAGE PEEK LUMBAR TAPERED FUSION DEVICE, THE LT CAGE LUMBER TAPERED FUSION DEVICE, AND THE INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE.
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