PMA P000054
- Device
- INFUSE BONE GRAFT
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S068
- Product code
- MPW
- Decision date
- 2026-08-26
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Approval order statement
- Approval for a change to the potency testing of rhBMP-2 used in the manufacturing of INFUSE Bone Graft.
Current openFDA PMA Record#
- Device
- INFUSE BONE GRAFT
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S075
- Product code
- MPW
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Decision date
- 2026-08-26
- Decision code
- APPR
- Date received
- 2025-03-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the potency testing of rhBMP-2 used in the manufacturing of INFUSE Bone Graft.