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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.
 
DeviceCONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS008
Date Received04/15/2002
Decision Date09/05/2002
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 a manufacturing site change and a design modification of the glucose sensor component of the continuous glucose monitoring system.
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