PMA P160007S052
- Device
- Simplera (TM) System
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S052
- Product code
- PQF
- Decision date
- 2024-09-17
- Classification
- Clinical Chemistry
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Approval order statement
- addition of two new sterilization chambers for sterilization of Simplera sensors. The Simplera sensor is a component of the Simplera System
Current openFDA PMA Record#
- Device
- Simplera (TM) System
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S052
- Product code
- PQF
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Decision date
- 2024-09-17
- Decision code
- OK30
- Date received
- 2024-08-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of two new sterilization chambers for sterilization of Simplera sensors. The Simplera sensor is a component of the Simplera System