PMA P160017S111

Device: Guardian 4 Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S111
Product code: OZP
Decision date: 2023-07-06
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: Addition of an alternate manufacturing site for the sensor fabrication process for the Guardian 4 Sensor (G4S). The G4S is a component of the MiniMed 780G System.

Current openFDA PMA Record#

Device: Guardian 4 Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S111
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2023-07-06
Decision code: OK30
Date received: 2023-06-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate manufacturing site for the sensor fabrication process for the Guardian 4 Sensor (G4S). The G4S is a component of the MiniMed 780G System.