PMA P160017S054
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S054
- Product code
- OZP
- Decision date
- 2019-02-21
- Classification
- Automated Insulin Dosing Device System, Single Hormonal Control
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Introduce a harvest/reclaim process for pump motors in the MiniMed 630G and 670G Pumps. The 630G and 670G Pumps are components of the MiniMed 630G and MiniMed 670G Systems.
Current openFDA PMA Record#
- Device
- MiniMed 670G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S054
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2019-02-21
- Decision code
- OK30
- Date received
- 2019-01-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce a harvest/reclaim process for pump motors in the MiniMed 630G and 670G Pumps. The 630G and 670G Pumps are components of the MiniMed 630G and MiniMed 670G Systems.