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 G4 PLATINUM Continuous Glucose Monitoring System, 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 | S082 |
Date Received | 06/11/2019 |
Decision Date | 08/20/2019 |
Product Codes |
MDS 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 changes to improve drop impact resistance to the receiver component of the Dexcom G4 PLATINUM Continuous Glucose Monitoring System and Dexcom G5 Mobile Continuous Glucose Monitoring System. |
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