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 |
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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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