MiniMed 670G (MMT-1780) System
FDA premarket approval P160017/S061 · decided 2019-07-09
Approval details
- PMA number
- P160017
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MiniMed 670G (MMT-1780) System
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2019-04-11
- Decision date
- 2019-07-09
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for design and manufacturing changes to the retainer ring component of the pump case assembly.
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