|
Device | MiniMed 630G System with Smart Guard |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150001 |
Supplement Number | S086 |
Date Received | 05/26/2020 |
Decision Date | 06/25/2020 |
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 Addition of a new piece of manufacturing equipment for CGM sensor coating. |