|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|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.