PMA P000054S074

Device: INFUSE® Bone Graft
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000054
Supplement: S074
Product code: MPW
Decision date: 2025-03-19
Classification: Orthopedic
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Approval order statement: change of the current ePCD for ethylene oxide sterilization, change to the temperature and relative humidity monitoring, change to the finished good release of the collagen based medical devices

Current openFDA PMA Record#

Device: INFUSE® Bone Graft
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000054
Supplement: S074
Product code: MPW
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Decision date: 2025-03-19
Decision code: OK30
Date received: 2025-03-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: change of the current ePCD for ethylene oxide sterilization, change to the temperature and relative humidity monitoring, change to the finished good release of the collagen based medical devices