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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINFUSE BONE GRAFT/Medtronic Interbody FUSION DEVICE
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS060
Date Received06/21/2016
Decision Date09/16/2016
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for increasing the size of the bioreactor used to manufacture rhBMP-2 from 6000 L to 12,000 L at the Pfizer Andover, MA Facility.
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