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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 NumberS229
Date Received11/14/2012
Decision Date06/06/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Pproval for the following new ellipse/quadra assura/fortify assura implantable cardioverter defibrillator (icd) and cardiac resynchronization therapy defibrillator (crt-d) models:1) ellipse vr icd (cd1411-36, cd1411-36q, cd1411-36c, cd1411-36qc); 2) fortify assura vr icd (cd1357-40, cd1357-40q, cd1357-40c, cd1357-40qc);3) ellipse dr icd (cd2411-36, cd2411-36q, cd2411-36c, cd2411-36qc);4) fortify assura dr icd (cd2357-40, cd2357-40q, cd2357-40c, cd2357-40qc);5) unify assura crt-d (cd3357-40, cd3357-40q, cd3357-40c, cd3357-40qc); and 6) quadra assura crt-d (cd3365-40, cd3365-40q, cd3365-40c, cd3365-40qc)as well as model 3330 version 17. 1 software for the model 3650 merlin patient care system programmer, model ex2000 version 6. 5 software for the models ex1150 and ex1100 merlin@home transmitters, and model mn5000 version 6. 5 software for the merlin. Net system.
Approval Order Approval Order