|Trade Name||FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Generic Name||sensor, glucose, invasive|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a process validation on the sharp manufactured at oberg industries (in freeport, pennsylvania) as well as to widen dimensional tolerances on the sharp in both length and angle bend. Currently all sharps produced at oberg must undergo 100% inspection at facet (in marietta, georga) prior to its assembling into the sensor inserter of the sensor delivery unit (sdu) of the freestyle navigator continuous glucose monitoring system. The process validation provided in this supplement will replace the 100% inspection requirement at facet.