Atlas FDA

Simplera™ System

FDA premarket approval P160007/S047 · decided 2024-07-24

Approval details

PMA number
P160007
Supplement
S047
Supplement type
Panel Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Simplera™ System
Generic name
Sensor, glucose, invasive, non-adjunctive
Applicant
Medtronic Minimed
Date received
2023-02-15
Decision date
2024-07-24
Days to decision
525 days
Decision code
APPR
Product code
PQF
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
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.

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510(k) clearances by this applicant

RecordFirmDate
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