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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, permanent, implantable
Generic Namepulse generator, permanent, implantable
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP880086
Supplement NumberS230
Date Received12/05/2012
Decision Date03/20/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
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.