- Device
- Infuse Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S063
- Product code
- MPW
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Decision date
- 2020-08-27
- Decision code
- OK30
- Date received
- 2020-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of vaccine drug substance protein manufacturing at the dibotermin alfa manufacturing site in Pfizers Andover, MA facility.