PMA P150001S105

Device: Medtronic MiniMed 630G System (MM630G)
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S105
Product code: OZO
Decision date: 2023-03-13
Classification: Clinical Chemistry
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Manufacturing change to expand the welding parameters used when manufacturing the pump case assembly. The pump case assembly is a component of the MiniMed 630G, MiniMed 670G, and MiniMed 770G systems.

Current openFDA PMA Record#

Device: Medtronic MiniMed 630G System (MM630G)
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S105
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2023-03-13
Decision code: OK30
Date received: 2023-02-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing change to expand the welding parameters used when manufacturing the pump case assembly. The pump case assembly is a component of the MiniMed 630G, MiniMed 670G, and MiniMed 770G systems.