PMA P000054S057
- Device
- Infuse Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S057
- Product code
- MPW
- Decision date
- 2019-11-29
- Classification
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Approval order statement
- Modifications to the post-approval stability protocol for the drug component of INFUSE Bone Graft.
Current openFDA PMA Record#
- Device
- Infuse Bone Graft
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000054
- Supplement
- S057
- Product code
- MPW
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Decision date
- 2019-11-29
- Decision code
- OK30
- Date received
- 2019-10-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the post-approval stability protocol for the drug component of INFUSE Bone Graft.