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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 NameQUICKSITE/QUICKFLEX LEADS/EPIC HF/+HF/EPIC II HF/II + HF/ATLAS HF/+ HF/II HF/II + HF/PROMOTE/PROMOTE + ICDS/CRT-DS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS143
Date Received12/24/2009
Decision Date01/22/2010
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the process water system monitoring frequency and locations at arecibo, puerto rico manufacturing facility.
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