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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 Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP030054
Supplement NumberS238
Date Received11/14/2012
Decision Date06/06/2013
Product Code
NIK[ Registered Establishments with NIK ]
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
Recalls CDRH Recalls
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