|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.|
|Classification Name||sensor, glucose, invasive|
|Supplement Type|| Special Supplement|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of product specification requirements for the glucose oxidase material used in the sof-sensors (models: mmt-7002 and mmt-7003) and the enlite sensor (model: mmt-7008).