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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS
Classification Nameprogrammer, pacemaker
Generic Nameprogrammer, pacemaker
Regulation Number870.3700
Applicant
Medtronic, Inc.
8200 coral sea street n.e.
mounds view, MN 55112
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/material
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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