|
Device | MiniMed 630G System with SmartGuard |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150001 |
Supplement Number | S008 |
Date Received | 12/14/2016 |
Decision Date | 06/02/2017 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding the Guardian Sensor (3) and Guardian Link (3) Transmitter to the MiniMed 630G System with SmartGuard, as well as lowering the approved age limit from 16 years old to 14 years old. |