PMA P050053S048
- Device
- INFUSE BONE GRAFT
- Applicant
- Medtronic, Inc.
- PMA number
- P050053
- Supplement
- S048
- Product code
- NPZ
- Decision date
- 2019-11-29
- Classification
- Bone Grafting Material, Dental, With Biologic Component
- Generic name
- Bone grafting material, dental, with biologic component
- 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, Inc.
- PMA number
- P050053
- Supplement
- S048
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- 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.