|
Device | Medtronic MiniMed 670G System |
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 | S040 |
Date Received | 03/26/2018 |
Decision Date | 05/23/2018 |
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 contamination controls at a supplier during manufacturing of liquid glucose oxidase. The glucose oxidase is used in production of Enlite and Guardian glucose sensors. |