PMA P150001
- Device
- Medtronic MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROC
- Applicant
- Medtronic Minimed
- PMA number
- P150001
- Supplement
- S102
- Product code
- OZO
- Decision date
- 2026-07-21
- Generic name
- Automated insulin dosing , threshold suspend
- Approval order statement
- undefined
Current openFDA PMA Record#
- Device
- Medtronic MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROC
- Applicant
- Medtronic Minimed
- PMA number
- P150001
- Supplement
- S111
- Product code
- OZO
- Generic name
- Automated insulin dosing , threshold suspend
- Decision date
- 2026-07-21
- Decision code
- OK30
- Date received
- 2026-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- undefined