PMA P250012
- Device
- Simplera Sync
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P250012
- Supplement
- S011
- Product code
- SFI
- Decision date
- 2026-07-21
- Classification
- Clinical Chemistry
- Generic name
- Sensor, Glucose, Invasive, Component of automated insulin delivery system
- Approval order statement
- undefined
Current openFDA PMA Record#
- Device
- Simplera Sync
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P250012
- Supplement
- S011
- Product code
- SFI
- Generic name
- Sensor, Glucose, Invasive, Component of automated insulin delivery system
- 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