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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 CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS
Classification Nameprogrammer, pacemaker
Generic Nameimplantable pulse generator
Regulation Number870.3700
Applicant MEDTRONIC INC.
PMA NumberP890003
Supplement NumberS253
Date Received07/05/2012
Decision Date01/29/2013
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Clinical Trials NCT00980057
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the viva/brava implantable cardioverter defibrillators with cardiac resynchronization (crt-d).
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