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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.
 
Trade NameCARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS173
Date Received10/29/2010
Decision Date11/29/2011
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for promote q model cd3221-36 crt-d, promote quadra models cd 3245-40/40q crt-d, unify quadra crt-d models cd3249-40/40q crt-d, quartet model 1458q lv lead, and model 3330 version 12. 1. 1 programmer software.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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