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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 NumberS002
Date Received10/24/2002
Decision Date07/29/2004
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR 1) THE EXTENSION OF THE LEVELS OF USE OF THE DEVICE FROM L4-S1 TO L2-S1 2) MODIFICATION OF THE INDICATION TO ALLOW FOR THE DEVICE TO BE USED IN SUBJECTS WHO MAY HAVE RETROLISTHESIS IN CONJUNCTION WITH DEGENERATIVE DISC DISEASE 3) CHANGE IN STORAGE TEMPERATURE LIMIT AND 4) REVISIONS TO INSTRUCTION FOR USE.
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