PMA P160017S048
- Device
- MiniMed 670G Insulin Pump Guardian Link (3) Transmitter
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S048
- Product code
- OZP
- Decision date
- 2018-11-20
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Approval for updating the transmitter firmware to improve user experience and to correct various software anomalies.
Current openFDA PMA Record#
- Device
- MiniMed 670G Insulin Pump Guardian Link (3) Transmitter
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S048
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2018-11-20
- Decision code
- APPR
- Date received
- 2018-07-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for updating the transmitter firmware to improve user experience and to correct various software anomalies.