PMA P160017S138
- Device
- Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4S
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S138
- Product code
- OZP
- Decision date
- 2026-07-21
- Classification
- Clinical Chemistry
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- undefined
Current openFDA PMA Record#
- Device
- Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4S
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S138
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- 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