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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 G5 Mobile Continuous Glucose Monitoring System
Generic Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 sequence dr
san diego, CA 92121
PMA NumberP120005
Supplement NumberS088
Date Received04/19/2021
Decision Date01/20/2022
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of continuous pediatric enrollment for the post-approval study (PAS) protocol.
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