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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 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 SEQUENCE DR
SAN DIEGO, CA 92121
PMA NumberP120005
Supplement NumberS001
Date Received12/05/2012
Decision Date01/04/2013
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  
SEMI-AUTOMATE THE SUB-ASSEMBLY DISPOSABLE SEAL (DS) PROCESS USED IN THE G4 CONTINUOUS GLUCOSE MONITORING SYSTEM. ADDITIONALLY, A NEW CLEAN ROOM WAS ADDED TO ACCOMMODATE THE NEW DISPOSABLE SEAL MACHINE AND PROVIDE ADDITIONAL MANUFACTURING CAPACITY FOR THE OTHER PROCESSES.
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