|
Device | Medtronic MiniMed Hybrid Closed Loop (HCL) 670G |
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 | S010 |
Date Received | 03/24/2017 |
Decision Date | 04/20/2017 |
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 Relocation of the molding process and a replacement press for the standoffs to a new manufacturing location for the 630G and 670G system. |