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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 Namesensor, glucose, invasive
Abbott Laboratories
1360 south loop road
alameda, CA 94502
PMA NumberP050020
Supplement NumberS004
Date Received04/30/2008
Decision Date10/08/2008
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the copilot health management system to be used in an accessory data management system with the freestyle navigator continuous glucose monitoring system.