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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 NumberS027
Date Received11/16/2007
Decision Date03/21/2008
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the following modifications to the package insert: 1) inclusion of warnings related to localized, transient bone resorption and possible nerve compression due to ectopic bone formation prompted by a labeling modification required by the eu as a result of an analysis of reported adverse events; 2) inclusion of clinical and adverse event data resulting from the clinical post approval study; 3) inclusion of a warning related to adverse events potentially associated with over stuffing the scaffold component into a small volume or hyperconcentrating the recombinant human protein component; 4) inclusion of references to previously approved xs and xxs kits; and 5) strengthening the language stating that the components of the product may only be used together and not with other devices or components, e. G. , scaffolds other than the acs.
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