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. |
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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 | S081 |
Date Received | 07/29/2020 |
Decision Date | 02/18/2022 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for extension of the expiration date from 18 to 24 months for three 1mg drug product lots manufactured at Hospira, Inc. (McPherson, Kansas) and seven 1mg drug product lots manufactured at Wyeth Farma S.A. (Algete, Spain) when stored at 5° and 30°C; addition of a 30 month timepoint to the long-term stability protocol studies performed at 30 ºC ± 2 ºC /75 ± 5% RH and 30 ºC ± 2 ºC /75 ± 5% RH; and discontinuation of testing at the 5°C long-term storage condition (current 5°C lots will continue to the end of the current study). |
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