MiniMed 670G System
FDA premarket approval P160017/S020 · decided 2017-12-08
Approval details
- PMA number
- P160017
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- 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
- 2017-09-27
- Decision date
- 2017-12-08
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for 1) minor design changes to the electronics board stack used in the 670G insulin pump; 2) a new supplier for the electronics board stack; 3) an updated pump software version; and 4) an extension to the 670G insulin pump shelf life from 185 days to 1095 days.
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