- Device
- Simplera and Simplera Sync
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S062
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2026-05-26
- Decision code
- OK30
- Date received
- 2026-04-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to increase the capacity for the degassing of Simplera and Simplera Sync sensors by adding an additional degassing aeration room (Degassing Room #3) at a sterilization facility. The Simplera sensor is a component of the Simplera system. The Simplera Sync sensor is a component of the MiniMed 780G system. The Simplera Sync sensor is also approved for use with compatible cleared MiniMed devices