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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.
Classification Namesensor, glucose, invasive
Generic Namecontinuous subcutaneous glucose monitoring system
PMA NumberP980022
Supplement NumberS012
Date Received02/28/2005
Decision Date08/24/2005
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the sensor to include the use of human serum albumin in place of bovine serum albumin as a stabilizer and a change to the manufacturing process removing the outer hydrophilic membrane.
Post-Approval StudyShow Report Schedule and Study Progress