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 | S005 |
Date Received | 05/20/2013 |
Decision Date | 08/14/2013 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE G4 PLATINUM FIRMWARE FOR THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM TO INCLUDE CODE REVISIONS AND FIRMWARE CHANGES TO IMPROVE COMMUNICATIONS, UPDATES TO THE FLASH MEMORY AND THE USB, PLUS A SINGLE CHANGE TO A DOCUMENTATION REVISION IN THE SOFTWARE REQUIREMENTS SPECIFICATION BUT NO CHANGES TO THE CODE WERE PERFORMED. |
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