PMA P250012S005

Device: Simplera Sync Sensor; Guardian 4 Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P250012
Supplement: S005
Product code: SFI
Decision date: 2025-12-10
Classification: Clinical Chemistry
Generic name: Sensor, Glucose, Invasive, Component of automated insulin delivery system
Approval order statement: addition of an alternate manufacturing site for the final assembly of the Guardian 4 Sensor. The Guardian 4 sensor is a component of the MiniMed 780G System

Current openFDA PMA Record#

Device: Simplera Sync Sensor; Guardian 4 Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P250012
Supplement: S005
Product code: SFI
Generic name: Sensor, Glucose, Invasive, Component of automated insulin delivery system
Decision date: 2025-12-10
Decision code: OK30
Date received: 2025-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of an alternate manufacturing site for the final assembly of the Guardian 4 Sensor. The Guardian 4 sensor is a component of the MiniMed 780G System