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 SYSTEMS |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 5555 OBERLIN DR SAN DIEGO, CA 92121 |
PMA Number | P050012 |
Supplement Number | S018 |
Date Received | 03/09/2009 |
Decision Date | 05/05/2009 |
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 DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO PROVIDE ADDITIONAL SUPPLEMENTARY INFORMATION TO USERS ON GLUCOSE TRENDS AND PATTERNS DOWNLOADED TO THE PROGRAM. THE SOFTWARE PROGRAM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM DATA MANAGER 3 (DM3) AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS OR SEVEN SYSTEMS INTO A PERSONAL COMPUTER (PC). THE SOFTWARE MODIFICATIONS INCLUDED SEVERAL NEW FEATURES AS IDENTIFIED IN THE SUBMISSION. |
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