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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 NumberS043
Date Received02/15/2011
Decision Date08/03/2012
Product Code NEK 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE SUBSTITUTION OF A QUALITY CONTROL TEST.
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