PMA P160017S049
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S049
- Product code
- OZP
- Decision date
- 2018-08-14
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Adding an alternative injection molding machine to produce the sleeve component used in the MiniMed 630G Pump and the MiniMed 670G Pump. The MiniMed 630G Pump is part of the MiniMed 630G System with SmartGuard and the MiniMed 670G pump is part of the MiniMed 670G System.
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S049
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2018-08-14
- Decision code
- OK30
- Date received
- 2018-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an alternative injection molding machine to produce the sleeve component used in the MiniMed 630G Pump and the MiniMed 670G Pump. The MiniMed 630G Pump is part of the MiniMed 630G System with SmartGuard and the MiniMed 670G pump is part of the MiniMed 670G System.