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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.
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Generic Namerecombinant human bone morphogenetic protein
PMA NumberP000054
Supplement NumberS033
Date Received10/20/2011
Decision Date07/17/2012
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee General & Plastic Surgery
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 you requested 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. ".