PMA P160017S074
- Device
- Medtronic MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S074
- Product code
- OZP
- Decision date
- 2019-11-04
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Packaging, labeling, and final release activities of the One-Press Serter conducted at Medtronic, Inc. to be moved to contract manufacturer facility. The One-Press Serter is a component of the 530G System, the 630G System, the 670G System, and the Guardian Connect System.
Current openFDA PMA Record#
- Device
- Medtronic MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S074
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2019-11-04
- Decision code
- OK30
- Date received
- 2019-10-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Packaging, labeling, and final release activities of the One-Press Serter conducted at Medtronic, Inc. to be moved to contract manufacturer facility. The One-Press Serter is a component of the 530G System, the 630G System, the 670G System, and the Guardian Connect System.