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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 NameMEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM: CARELINK PRO, MMT-7335 VERSION 3.0B
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS086
Date Received09/17/2010
Decision Date11/01/2010
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the carelink pro (mmt-7335)-therapy management software for diabetes, from version 3. 0a to 3. 0b.
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