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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
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Generic Namerecombinant human bone morphogenetic protein
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
PMA NumberP000054
Supplement NumberS019
Date Received12/02/2008
Decision Date01/20/2010
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an additional supplier of bovine achilles tendon for the manufacture of the absorbable collagen sponge (acs) component of the infuse bone graft.
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