- Device
- iPro2 CGM System with Enlite Sensor
- Applicant
- Medtronic Minimed
- PMA number
- P150029
- Supplement
- S035
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2020-12-01
- Decision code
- OK30
- Date received
- 2020-11-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing changes related to bioburden testing for the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor is component of the MiniMed 530G System, the MiniMed 630G System, the Paradigm Real-Time Revel System, and the iPro2 CGM System. The Guardian Sensor (3) is component of the MiniMed 670G System, the Guardian Connect System, and the MiniMed 630G System with SmartGuard.