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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 NumberS001
Date Received05/20/2004
Decision Date06/10/2004
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for 1) an increase in the expiration date of the 4. 2 and 12 mg vialed rhbmp-2 component of the referenced devices from 36 to 48 months; 2) an increase in the expiration date of the commercial kit component from 24 to 36 months; and 3) the protocol to be followed for all future expiration date changes.