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 | G5 Mobile transmitter Hardware and Firmware, 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 | S073 |
Date Received | 04/04/2018 |
Decision Date | 07/03/2018 |
Product Code |
PQF |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for minor design changes to the Dexcom G5 transmitter hardware and firmware. The Dexcom G5 transmitter is part of the Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM). |
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