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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 NameCARELINK PRO PC SOFTWARE
Classification Namesensor, glucose, invasive
Generic Namecontinuous subcutaneous glucose monitoring system
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS034
Date Received08/29/2008
Decision Date11/24/2008
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update of software used in the carelink pro, model mmt-7335 to version 1. 2a.
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