PMA P160007S054

Device: Guardian Connect System
Applicant: Medtronic Minimed
PMA number: P160007
Supplement: S054
Product code: MDS
Decision date: 2025-10-09
Classification: Clinical Chemistry
Generic name: Sensor, glucose, invasive
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 Connect System
Applicant: Medtronic Minimed
PMA number: P160007
Supplement: S054
Product code: MDS
Generic name: Sensor, glucose, invasive
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.