Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Devices@FDA
  • Print
  • Share
  • E-mail
-
 
Help | Download Files | More about PMA

New Search Back to Search Results
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 CONTINOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS013
Date Received09/30/2013
Decision Date02/26/2014
Withdrawal Date03/20/2026
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01514292
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR END OF LIFE COMPONENT CHANGES (SPEAKER DRIVER-CODEC, FLASH, MOSFET, SDRAM, CAPACITOR (CAP), AND RF CHIP) IN THE RECEIVER PRINTED CIRCUIT BOARD ASSEMBLY, USE OF A HIGHER CAPACITY CAPACITOR AND IMPROVEMENT IN THE METHOD OF ATTACHMENT OF A USB PORT CONNECTOR IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
  We welcome your comments and feedback about Devices@FDA.
-
-