Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Dexcom G5 Mobile Continuous Glucose Monitoring System |
Generic Name | Sensor, glucose, invasive, non-adjunctive |
Applicant | DEXCOM, INC. 6340 SEQUENCE DR SAN DIEGO, CA 92121 |
PMA Number | P120005 |
Supplement Number | S050 |
Date Received | 06/22/2016 |
Decision Date | 03/08/2017 |
Product Code |
PQF |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new touchscreen receiver component for the G5 Mobile Continuous Glucose Monitoring (CGM) System |
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