- Device
- Infuse Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S054
- Product code
- MPW
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Decision date
- 2020-02-04
- Decision code
- APPR
- Date received
- 2019-08-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for introduction of additional cell lines and the use of related raw materials into Pfizers Andover, Massachusetts facility.