PMA P250012

Device: Simplera Sync Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P250012
Supplement: S009
Product code: SFI
Decision date: 2026-03-19
Classification: Clinical Chemistry
Generic name: Sensor, Glucose, Invasive, Component of automated insulin delivery system
Approval order statement: to add the Medtronic Northridge facility as an additional site for conducting post-sterilization quality testing for the Simplera Sync sensor. The Simplera Sync sensor is a component of the MiniMed 780G System

Current openFDA PMA Record#

Device: Simplera Sync Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P250012
Supplement: S009
Product code: SFI
Generic name: Sensor, Glucose, Invasive, Component of automated insulin delivery system
Decision date: 2026-03-19
Decision code: OK30
Date received: 2026-02-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add the Medtronic Northridge facility as an additional site for conducting post-sterilization quality testing for the Simplera Sync sensor. The Simplera Sync sensor is a component of the MiniMed 780G System