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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceTHE DEXCOM SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
5555 Oberlin Dr.
San Diego, CA 92121
PMA NumberP050012
Supplement NumberS017
Date Received09/23/2008
Decision Date12/03/2008
Withdrawal Date08/28/2015
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS MADE TO THE RECEIVER SUB-COMPONENT PCBA AND HOUSING; MANUFACTURING PROCESSES OF THE RECEIVER TO ACCOMMODATE A REVISED PCBA; AND OUTSOURCING OF THE ALTERNATIVE RECEIVER MANUFACTURING PROCESS.
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