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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 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 NameFREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namecontinuous glucose monitor
ApplicantABBOTT LABORATORIES
PMA NumberP050020
Supplement NumberS017
Date Received08/13/2009
Decision Date01/19/2010
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product 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.
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