Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MiniMed 670G System |
Generic Name | Automated insulin dosing device system, single hormonal control |
Applicant | MEDTRONIC MINIMED, INC. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325 |
PMA Number | P160017 |
Supplement Number | S051 |
Date Received | 08/31/2018 |
Decision Date | 11/29/2018 |
Product Code |
OZP |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a minor software design change to fix an anomaly in the main application software used in a specific hardware configuration. |
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