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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 G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive, non-adjunctive
Generic Namesensor, glucose, invasive, non-adjunctive
Applicant
DEXCOM, INC.
6340 sequence dr
san diego, CA 92121
PMA NumberP120005
Supplement NumberS059
Date Received01/19/2017
Decision Date05/22/2017
Product Code
PQF[ Registered Establishments with PQF ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the revised protocol for the post-approval study (PAS) protocol.
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