PMA P050053S051
- Device
- Infuse Bone Graft
- Applicant
- Medtronic, Inc.
- Product code
- NPZ
- Decision date
- 2021-11-08
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- Approval for the use of a new lyophilizer in the manufacture of dibotermin alfa, a component of Infuse Bone Graft.
Current openFDA PMA Record#
- Device
- Infuse Bone Graft
- Applicant
- Medtronic, Inc.
- PMA number
- P050053
- Supplement
- S051
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2021-11-08
- Decision code
- APPR
- Date received
- 2020-07-08
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the use of a new lyophilizer in the manufacture of dibotermin alfa, a component of Infuse Bone Graft.