- Device
- INFUSE™ Bone Graft
- Applicant
- Medtronic, Inc.
- PMA number
- P050053
- Supplement
- S064
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2024-11-06
- Decision code
- OK30
- Date received
- 2024-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change for the replacement of the data acquisition (DAQ) system component on the shrink temperature testing instrument in the quality control (QC) analytical lab