PMA P050053S065

Device: INFUSE® Bone Graft
Applicant: Medtronic, Inc.
PMA number: P050053
Supplement: S065
Product code: NPZ
Decision date: 2025-03-19
Classification: Dental
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: change of the current ePCD for ethylene oxide sterilization, change to the temperature and relative humidity monitoring, change to the finished good release of the collagen based medical devices

Current openFDA PMA Record#

Device: INFUSE® Bone Graft
Applicant: Medtronic, Inc.
PMA number: P050053
Supplement: S065
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2025-03-19
Decision code: OK30
Date received: 2025-03-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: change of the current ePCD for ethylene oxide sterilization, change to the temperature and relative humidity monitoring, change to the finished good release of the collagen based medical devices