PMA P050053S059
- Device
- Infuse™ Bone Graft
- Applicant
- Medtronic, Inc.
- PMA number
- P050053
- Supplement
- S059
- Product code
- NPZ
- Decision date
- 2022-08-09
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- Replacement of the water purification system used in manufacture of the collagen sponge component.
Current openFDA PMA Record#
- Device
- Infuse™ Bone Graft
- Applicant
- Medtronic, Inc.
- PMA number
- P050053
- Supplement
- S059
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2022-08-09
- Decision code
- OK30
- Date received
- 2022-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the water purification system used in manufacture of the collagen sponge component.