- Device
- Infuse Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S061
- Product code
- MPW
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Decision date
- 2020-12-30
- Decision code
- APPR
- Date received
- 2020-07-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change in the preparation of stopper components used in the manufacture of the product.