|
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 | S017 |
Date Received | 08/02/2017 |
Decision Date | 02/13/2018 |
Product Code |
OZP |
Docket Number | 18M-0738 |
Notice Date | 03/14/2018 |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding the upper arm as an alternate insertion site for the Guardian Sensor (3). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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