|
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 | S066 |
Date Received | 08/17/2017 |
Decision Date | 09/09/2017 |
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 Modification to transmitter machining and polishing processes for transmitters that are components of the Dexcom G5 Mobile/G4 PLATINUM Continuous Glucose Monitoring Systems. |