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Device | 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 | S051 |
Date Received | 07/15/2016 |
Decision Date | 08/12/2016 |
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 Extending the temperature excursion period for the Dexcom G5 Mobile/G4 PLATINUM Sensor. The proposed change seeks to extend the allowable temperature excursion period for the sensor component in its primary packaging. The Dexcom G5 Mobile/G4 PLATINUM Sensor is a component of the Dexcom G5 Mobile and the Dexcom G4 Platinum Continuous Glucose Monitoring System, respectively. |