PMA P050053S067

Device: INFUSE Bone Graft
Applicant: Medtronic, Inc.
PMA number: P050053
Supplement: S067
Product code: NPZ
Decision date: 2026-02-24
Classification: Dental
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: Change to upgrade the EO Sterilization Chamber Control System at the contract sterilization site from the Antares Chamber Control System to the Konnexis AccuSOLO Chamber Control System

Current openFDA PMA Record#

Device: INFUSE Bone Graft
Applicant: Medtronic, Inc.
PMA number: P050053
Supplement: S067
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2026-02-24
Decision code: OK30
Date received: 2026-01-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to upgrade the EO Sterilization Chamber Control System at the contract sterilization site from the Antares Chamber Control System to the Konnexis AccuSOLO Chamber Control System