- Device
- Infuse Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S067
- Product code
- MPW
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Decision date
- 2022-06-09
- Decision code
- OK30
- Date received
- 2022-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of sterile connectors in the filtration and filling equipment lines for the rhBMP-2 drug product at the Hospira McPherson, KS facility.