|
Device | Medtronic MiniMed 670G System / Giardian Senor (3) |
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 | S046 |
Date Received | 07/02/2018 |
Decision Date | 08/03/2018 |
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 Addition of an alternative press to increase manufacturing capacity for the Guardian Sensor (3) continuous glucose monitoring sensor. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect System, and MiniMed 670G systems. |