- Device
- Paradigm real time Insulin Pump / Paradigm Real time revel Insulin Pump
- Applicant
- Medtronic Minimed
- PMA number
- P980022
- Supplement
- S202
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2018-02-28
- Decision code
- OK30
- Date received
- 2018-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of O-ring supplier for MiniMed 630G, 670G, and Paradigm REAL-Time family of insulin pumps, which are components of the MiniMed 670G System, MiniMed 630G System with SmartGuard, MiniMed Paradigm Real-Time Revel System with Enlite Sensor, MiniMed 530G System, and MiniMed Paradigm Real-Time Revel System.