PMA P120010
- Device
- Enlite Sensor
- Applicant
- Medtronic, Inc.
- PMA number
- P120010
- Supplement
- S142
- Product code
- OZO
- Decision date
- 2026-07-21
- Generic name
- Automated insulin dosing , threshold suspend
- Approval order statement
- undefined
Current openFDA PMA Record#
- Device
- Enlite Sensor
- Applicant
- Medtronic, Inc.
- PMA number
- P120010
- Supplement
- S144
- 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