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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 Pl.
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS082
Date Received07/30/2020
Decision Date08/27/2020
Product Code NEK 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Introduction of vaccine drug substance protein manufacturing at the dibotermin alfa manufacturing site in Pfizers Andover, MA facility.
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