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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 NumberS048
Date Received10/20/2011
Decision Date07/17/2012
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the labeling for the identified products. Specifically requested was the following: 1) an additional warning to address concerns related to the use of potential patients with a suspected malignancy; 2) an additional warning related to device migration; 3) a modification to the precaution related to ectopic, heterotopic and exuberant bone formation by removing the initial qualifying language: and 4) a modification to the description of the reconstituted recombinant protein solution, i. E. , ". Colorless to slightly yellow. ".
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