PMA P250012
- Device
- Simplera Sync Sensor
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P250012
- Supplement
- S008
- Product code
- SFI
- Decision date
- 2026-06-12
- Classification
- Clinical Chemistry
- Generic name
- Sensor, Glucose, Invasive, Component of automated insulin delivery system
- Approval order statement
- Approval for updating the sensor compressor dimensions in the Synergy Sensor (Simplera) assembly.
Current openFDA PMA Record#
- Device
- Simplera Sync Sensor
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P250012
- Supplement
- S008
- Product code
- SFI
- Generic name
- Sensor, Glucose, Invasive, Component of automated insulin delivery system
- Decision date
- 2026-06-12
- Decision code
- APPR
- Date received
- 2026-01-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updating the sensor compressor dimensions in the Synergy Sensor (Simplera) assembly.