PMA P160017S043
- Device
- MiniMed 670G System Pump
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S043
- Product code
- OZP
- Decision date
- 2018-07-02
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Addition of a laser welding equipment for the fabrication of the drive motor assembly parts used in the MiniMed 630G Pump and the MiniMed 670G Pump, part of MiniMed 630G System with SmartGuard, and MiniMed 670G System respectively.
Current openFDA PMA Record#
- Device
- MiniMed 670G System Pump
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S043
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2018-07-02
- Decision code
- OK30
- Date received
- 2018-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a laser welding equipment for the fabrication of the drive motor assembly parts used in the MiniMed 630G Pump and the MiniMed 670G Pump, part of MiniMed 630G System with SmartGuard, and MiniMed 670G System respectively.