PMA P160017S058
- Device
- Guardian Link (3) Transmitter (MiniMed 670G System)
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S058
- Product code
- OZP
- Decision date
- 2019-03-21
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- New manufacturing site for the transmitter components of the Guardian Connect System, the MiniMed 630G System, and the MiniMed 670G System.
Current openFDA PMA Record#
- Device
- Guardian Link (3) Transmitter (MiniMed 670G System)
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S058
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2019-03-21
- Decision code
- OK30
- Date received
- 2019-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New manufacturing site for the transmitter components of the Guardian Connect System, the MiniMed 630G System, and the MiniMed 670G System.