PMA P050053S054
- Device
- Infuse Bone Graft
- Applicant
- Medtronic, Inc.
- PMA number
- P050053
- Supplement
- S054
- Product code
- NPZ
- Decision date
- 2020-08-27
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- Introduction of vaccine drug substance protein manufacturing at the dibotermin alfa manufacturing site in Pfizer’s Andover, MA facility.
Current openFDA PMA Record#
- Device
- Infuse Bone Graft
- Applicant
- Medtronic, Inc.
- PMA number
- P050053
- Supplement
- S054
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2020-08-27
- Decision code
- OK30
- Date received
- 2020-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of vaccine drug substance protein manufacturing at the dibotermin alfa manufacturing site in Pfizer’s Andover, MA facility.