|
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 | S026 |
Date Received | 10/10/2017 |
Decision Date | 11/07/2017 |
Product Code |
OZO |
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 New electroplating machine to increase manufacturing capacity for the Guardian Sensor (3) continuous glucose monitoring sensor. The Guardian Sensor (3) is a component of the MiniMed 630G and MiniMed 670G systems. |