PMA P160017S073
- Device
- MiniMed 670G Insulin System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S073
- Product code
- OZP
- Decision date
- 2019-10-30
- 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 new curing process to increase production capacity of the MiniMed 630G Insulin Pump and the MiniMed670G Insulin Pump. The MiniMedi 630G Insulin pump is a component of the MiniMed 630G System with Smartguard. The MiniMed 670G Insulin Pump is a component of the MiniMed 670G System.
Current openFDA PMA Record#
- Device
- MiniMed 670G Insulin System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S073
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2019-10-30
- Decision code
- OK30
- Date received
- 2019-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new curing process to increase production capacity of the MiniMed 630G Insulin Pump and the MiniMed670G Insulin Pump. The MiniMedi 630G Insulin pump is a component of the MiniMed 630G System with Smartguard. The MiniMed 670G Insulin Pump is a component of the MiniMed 670G System.