- Device
- MiniMed 770G Insulin Pump
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S103
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2022-10-27
- Decision code
- OK30
- Date received
- 2022-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a reclamation process to allow printed circuit board assemblies to be reused for construction of MiniMed 770G pumps. The 770G insulin pump is a component of the MiniMed 770G system.