- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S126
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2025-08-25
- Decision code
- OK30
- Date received
- 2025-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to update the inspection requirements performed by Medtronic Tempe Campus (MTC) on a component used in the glucose sensor Printed Circuit Board Assembly (PCBA). The PCBA is a component of the Minimed 670G system, Guardian connect system, and Simplera sync sensor, guardian 4 sensor