- Device
- Guardian Connect System
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S037
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2020-09-02
- Decision code
- OK30
- Date received
- 2020-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IntriCon Corporation (IntriCon Red Fox), 1260 Red Fox Road, Saint Paul, MN as an alternative finished product manufacturing facility and IntriCon Corporation Grey Fox (IntriCon Grey Fox), 1275 Grey Fox Road Arden Hills, MN as an alternate final packaging process facility for the Guardian Link (3) and Guardian Connect Transmitter. The transmitters are components of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The submission also requested approval of process changes related to the new manufacturing facilities including a new inspection process and equipment.