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 SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 5555 OBERLIN DR SAN DIEGO, CA 92121 |
PMA Number | P050012 |
Supplement Number | S052 |
Date Received | 12/06/2013 |
Decision Date | 03/05/2014 |
Withdrawal Date
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08/28/2015 |
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 THE FOLLOWING CHANGES TO THE DEXCOM STUDIO SOFTWARE: SUPPORT WAS ADDED FOR WINDOWS 8, OPEN OFFICE, AND CANADIAN ENGLISH AND CANADIAN FRENCH INSTALLATIONS; IMPROVED SYSTEM PERFORMANCE FOR LARGE CLINICS THAT MANAGE LARGE NUMBERS OF PATIENTS; THE WORD BLINDED WAS ADDED TO EVERY CHART WHEN THE RECEIVER DATA IS DOWNLOADED IN BLINDED MODE; THE TOOLTIP WAS TRANSLATED INTO VARIOUS LANGUAGES; AND LABELING CHANGES WERE MADE TO THE DEXCOM STUDIO SOFTWARE GUIDE, G4 SENSOR MANUAL, AND RECEIVER REPLACEMENT GUIDE. |
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