MiniMed 670G System
FDA premarket approval P160017/S018 · decided 2017-10-31
Approval details
- PMA number
- P160017
- Supplement
- S018
- 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
- 2017-08-04
- Decision date
- 2017-10-31
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for design changes to the Contour Next Link 2.4 Wireless Blood Glucose Meter. The Contour Next Link 2.4 Wireless Blood Glucose Meter is a component of the Medtronic MiniMed 630G System and Medtronic MiniMed 670G System.
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