PMA P050053S056
- Device
- INFUSE Bone Graft
- Applicant
- Medtronic, Inc.
- PMA number
- P050053
- Supplement
- S056
- Product code
- NPZ
- Decision date
- 2021-04-06
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- Modification to the cleaning process used in manufacture of the absorbable collagen sponge component of the INFUSE bone graft product.
Current openFDA PMA Record#
- Device
- INFUSE Bone Graft
- Applicant
- Medtronic, Inc.
- PMA number
- P050053
- Supplement
- S056
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2021-04-06
- Decision code
- OK30
- Date received
- 2021-03-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the cleaning process used in manufacture of the absorbable collagen sponge component of the INFUSE bone graft product.