- Device
- Guardian Sensor 3
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S050
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2024-01-05
- Decision code
- OK30
- Date received
- 2023-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to increase the allowable maximum sterilization dose for the Guardian Sensor (3) and Guardian 4 Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G Systems, MiniMed 630G System with Smart Guard, and Guardian Connect Systems. The Guardian 4 Sensor is a component of the MiniMed 780G System