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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 NameST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS146
Date Received02/05/2010
Decision Date05/03/2010
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: 1) the addition of the pacing systems analyzer (psa) model ex3100. The model ex3100 also includes accessories: a) merlin antenna adapter ex3190; b) merlin cable adapter ex3170; and c) merlin ¿m¿ adapter ex3180; and 2) the addition of the model 3330 version 10. 1. 1 software.
Approval Order Approval Order
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