PMA P160017S119

Device: Guardian 4 Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S119
Product code: OZP
Decision date: 2024-07-17
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: a new sterilization site for the sterilization of the Guardian Sensor (4) sensors that are manufactured at Medtronic Puerto Rico Operations Company. The Guardian Sensor (4) is a component of the Guardian Connect system and the MiniMed 670G, 770G, and 780G systems

Current openFDA PMA Record#

Device: Guardian 4 Sensor
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S119
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2024-07-17
Decision code: OK30
Date received: 2024-06-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a new sterilization site for the sterilization of the Guardian Sensor (4) sensors that are manufactured at Medtronic Puerto Rico Operations Company. The Guardian Sensor (4) is a component of the Guardian Connect system and the MiniMed 670G, 770G, and 780G systems