|
Device | 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 | S090 |
Date Received | 10/14/2022 |
Decision Date | 01/12/2023 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to modify the prior inclusion criterion to the following: Clinical diagnosis of Type 1 or Type 2 diabetes with at least one (1) week of insulin initiation at time of study entry. |