|
Device | MiniMed 670G Insulin Pump |
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 | S013 |
Date Received | 05/08/2017 |
Decision Date | 06/06/2017 |
Product Code |
OZP |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Changes to update tester software that performs a series of tasks during final acceptance activities, after 630G and 670G insulin pumps have been fully assembled. The 630G insulin pump is part of the MiniMed 630G system and the 670G insulin pump is part of the MiniMed 670G system. |