PMA P000054
- Device
- INFUSE® Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S068
- Product code
- MPW
- Decision date
- 2026-03-19
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Approval order statement
- addition of an alternate testing facility and relocation of relevant laboratories to a new building
Current openFDA PMA Record#
- Device
- INFUSE® Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S077
- Product code
- MPW
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Decision date
- 2026-03-19
- Decision code
- OK30
- Date received
- 2026-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an alternate testing facility and relocation of relevant laboratories to a new building