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 |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 6340 SEQUENCE DR SAN DIEGO, CA 92121 |
PMA Number | P120005 |
Supplement Number | S038 |
Date Received | 08/10/2015 |
Decision Date | 11/06/2015 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE PACKAGING DESIGN FOR THE SENSOR/ APPLICATOR FOR THE G4 PLATINUM CGM SYSTEM AND THE MANUFACTURING LINE FOR THIS NEW PACKAGING. |
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