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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceDEXCOM SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
5555 OBERLIN DR
SAN DIEGO, CA 92121
PMA NumberP050012
Supplement NumberS036
Date Received01/31/2011
Decision Date03/02/2011
Withdrawal Date 08/28/2015
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALTERNATE VENDOR AND METHOD OF MANUFACTURE OF THE DISPOSABLE SEAL COMPONENT OF THE APPLICATOR ASSEMBLY OF THE SEVEN AND SEVEN PLUS SYSTEMS. THE PROPOSED CHANGE APPLIES ONLY TO THE DISPOSABLE SEAL SUPPLIER AND THE METHOD OF MANUFACTURE; NEITHER THE MATERIALS NOR THE FINAL DESIGN OF THE DISPOSABLE SEAL ARE ALTERED. SENSOR PERFORMANCE AND RELEASE SPECIFICATION WILL ALSO REMAIN UNCHANGED.
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