PMA P160007S047

Device: Simplera™ System
Applicant: Medtronic Minimed
PMA number: P160007
Supplement: S047
Product code: PQF
Decision date: 2024-07-24
Classification: Clinical Chemistry
Generic name: Sensor, glucose, invasive, non-adjunctive
Approval order statement: Approval for the Simplera system. The Simplera system is a real-time continuous glucose monitoring (CGM) system indicated for the management of diabetes in persons ages 18 years and older. The Simplera system does not require calibration and is designed to replace fingerstick blood glucose (BG) testing for diabetes treatment decisions, unless otherwise indicated. Interpretation of the Simplera system results should be based on the glucose trends and several sequential sensor readings over time.

Current openFDA PMA Record#

Device: Simplera™ System
Applicant: Medtronic Minimed
PMA number: P160007
Supplement: S047
Product code: PQF
Generic name: Sensor, glucose, invasive, non-adjunctive
Decision date: 2024-07-24
Decision code: APPR
Date received: 2023-02-15
Supplement type: Panel Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Simplera system. The Simplera system is a real-time continuous glucose monitoring (CGM) system indicated for the management of diabetes in persons ages 18 years and older. The Simplera system does not require calibration and is designed to replace fingerstick blood glucose (BG) testing for diabetes treatment decisions, unless otherwise indicated. Interpretation of the Simplera system results should be based on the glucose trends and several sequential sensor readings over time.