|
Device | Infuse Bone Graft/Medtronic Interbody Fusion Device |
Generic Name | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P000058 |
Supplement Number | S079 |
Date Received | 07/08/2020 |
Decision Date | 11/08/2021 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the use of a new lyophilizer in the manufacture of dibotermin alfa, a component of Infuse Bone Graft. |