PMA P000058S081

Device: Infuse Bone Graft/Medtronic Interbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: NEK
Decision date: 2022-02-18
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
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).

Current openFDA PMA Record#

Device: Infuse Bone Graft/Medtronic Interbody Fusion Device
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S081
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Decision date: 2022-02-18
Decision code: APPR
Date received: 2020-07-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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).