|
Device | Dexcom G5 Mobile Continuous Glucose Monitoring System |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 6340 SEQUENCE DR SAN DIEGO, CA 92121 |
PMA Number | P120005 |
Supplement Number | S086 |
Date Received | 12/09/2019 |
Decision Date | 01/08/2020 |
Product Code |
MDS |
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 Clean Environment Room and associated support rooms to the existing manufacturing space for manufacturing sensors of the G4 PLATINUM/G5 Mobile Continuous Glucose Monitoring (CGM) System. |