|
Device | MiniMed 630G Insulin Pump |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150001 |
Supplement Number | S028 |
Date Received | 10/30/2017 |
Decision Date | 12/20/2017 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for 1) minor design changes to the electronics board stack used in the 630G insulin pump; 2) a new supplier for the electronics board stack; 3) an updated pump software version; and 4) an extension to the 630G insulin pump shelf life from 185 days to 1095 days. |