MiniMed 670G System
FDA premarket approval P160017/S028 · decided 2018-02-14
Approval details
- PMA number
- P160017
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MiniMed 670G System
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2017-11-30
- Decision date
- 2018-02-14
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for design changes to the ball bearing components of the drive motor assembly used in the MiniMed 630G pump and the MiniMed 670G pump. The MiniMed 630G and 670G pumps are components of the MiniMed 630G System and the MiniMed 670G System, respectively.
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