PMA P160007S058
- Device
- MiniMed Go app; Simplera sensor
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S058
- Product code
- MDS
- Decision date
- 2026-01-23
- Classification
- Clinical Chemistry
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- for a predetermined change control plan (PCCP) regarding alternate primary user interfaces and maintaining compatibility with alternate display devices.
Current openFDA PMA Record#
- Device
- MiniMed Go app; Simplera sensor
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S058
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2026-01-23
- Decision code
- APPR
- Date received
- 2025-11-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- for a predetermined change control plan (PCCP) regarding alternate primary user interfaces and maintaining compatibility with alternate display devices.