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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.
 
DeviceSENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP880006
Supplement NumberS085
Date Received12/05/2012
Decision Date03/20/2014
Withdrawal Date 05/07/2018
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100.
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