- Device
- MiniMed 630G System with SmartGuard
- Applicant
- Medtronic Minimed
- PMA number
- P150001
- Supplement
- S090
- Product code
- OZO
- Generic name
- Automated insulin dosing , threshold suspend
- Decision date
- 2021-02-25
- Decision code
- APPR
- Date received
- 2021-01-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an update to product labeling to warn against a new interference by Hydroxyurea to the continuous glucose monitoring (CGM) component of the system.