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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 NameCONTINUOUS GLUCOSE MONITORING SYSTEM
Generic Namecontinuous subcutaneous glucose monitoring system
ApplicantMINIMED, INC.
PMA NumberP980022
Supplement NumberS006
Date Received09/21/2000
Decision Date01/09/2001
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing site for the manufacturer of the external components of the device. The new site is minimed, inc. , northridge, california.
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