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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Generic Nameinvertebral lumbar device
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
PMA NumberP000058
Supplement NumberS041
Date Received09/30/2010
Decision Date08/03/2012
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to tests performed as part of the ongoing drug product stability program for rhbmp-2 (dibotermin alfa).
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