- Device
- iPro™ 2 CGM System with Enlite™ Glucose Sensor
- Applicant
- Medtronic Minimed
- PMA number
- P150029
- Supplement
- S037
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2021-12-17
- Decision code
- APPR
- Date received
- 2021-11-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling update to provide additional clarity on an existing warning for acetaminophen interference to the continuous glucose monitoring (CGM) component of the system.