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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 NumberS003
Date Received02/14/2000
Decision Date03/10/2000
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the sen-serter auto inserter to be used with the minimed continuous glucose monitoring system as an aid for insertion of the mimimed glucose sensor.
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