PMA P160017S125
- Device
- MiniMed 780G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S125
- Product code
- OZP
- Decision date
- 2025-12-11
- Classification
- Clinical Chemistry
- Generic name
- Automated insulin dosing device system, single hormonal control
- Approval order statement
- Approval of expanding the compatible insulins for use with the MiniMed 780G system to include Fiasp and Lyumjev.
Current openFDA PMA Record#
- Device
- MiniMed 780G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S125
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2025-12-11
- Decision code
- APPR
- Date received
- 2025-04-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of expanding the compatible insulins for use with the MiniMed 780G system to include Fiasp and Lyumjev.