PMA P250012S002

Device: Guardian 4 Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P250012
Supplement: S002
Product code: SFI
Decision date: 2025-10-09
Classification: Clinical Chemistry
Generic name: Sensor, Glucose, Invasive, Component of automated insulin delivery system
Approval order statement: Approval for a manufacturing site located at Minimed Kentucky Distribution Center (aka UPS Supply Chain Solutions), 1860 Outer Loop #326, Louisville, KY 40219, USA, FEI 3006759904, for repacking and labeling.

Current openFDA PMA Record#

Device: Guardian 4 Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P250012
Supplement: S002
Product code: SFI
Generic name: Sensor, Glucose, Invasive, Component of automated insulin delivery system
Decision date: 2025-10-09
Decision code: APPR
Date received: 2025-08-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Minimed Kentucky Distribution Center (aka UPS Supply Chain Solutions), 1860 Outer Loop #326, Louisville, KY 40219, USA, FEI 3006759904, for repacking and labeling.