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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.
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
PMA NumberP010015
Supplement NumberS227
Date Received12/18/2013
Decision Date07/09/2014
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the medtronic viva crt-p model c6tr01 implantable pacemaker with cardiac resynchronization; programmer software application model 9995 v8. 3; and updates to the medtronic carelink monitor model 2490g, cardiosight reader model 2020a and carelink express model 2020b firmware, and to the model 2491 device data management application (ddma).
Approval Order Approval Order