PMA P000058S071
- Device
- Infuse Bone Graft/Medtronic Interbody Fusion Device
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000058
- Supplement
- S071
- Product code
- NEK
- Decision date
- 2019-01-15
- Classification
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Approval order statement
- Approval for an additional 6000 L bioreactor to be located in Building B, Suite C/D at the Andover site.
Current openFDA PMA Record#
- Device
- Infuse Bone Graft/Medtronic Interbody Fusion Device
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000058
- Supplement
- S071
- Product code
- NEK
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Decision date
- 2019-01-15
- Decision code
- APPR
- Date received
- 2018-10-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an additional 6000 L bioreactor to be located in Building B, Suite C/D at the Andover site.