PMA P160007S036
- Device
- Guardian Connect System
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S036
- Product code
- MDS
- Decision date
- 2020-06-25
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Addition of a new piece of manufacturing equipment for CGM sensor coating.
Current openFDA PMA Record#
- Device
- Guardian Connect System
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S036
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2020-06-25
- Decision code
- OK30
- Date received
- 2020-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new piece of manufacturing equipment for CGM sensor coating.