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/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 | S075 |
Date Received | 05/18/2018 |
Decision Date | 06/15/2018 |
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 Addition of a new supplier of glucose oxidase for manufacture of glucose sensors for G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems. |
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