- Device
- Medtronic MiniMed 630G insulin pump
- Applicant
- Medtronic Minimed
- PMA number
- P150001
- Supplement
- S096
- Product code
- OZO
- Generic name
- Automated insulin dosing , threshold suspend
- Decision date
- 2022-04-28
- Decision code
- OK30
- Date received
- 2022-03-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing changes for the next generation pump (NGP) case assembly. The NGP case assembly is a component of the Medtronic MiniMed 630G, 670G, and 770G insulin pump systems.