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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)
PMA NumberP030035
Supplement NumberS115
Date Received11/21/2013
Decision Date02/26/2014
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the following software packages to be used with the devices. Those software packages are: model 3330 version 18. 1 software for the model 3650 patient care system (pcs) programmer; model ex2000 version 7. 0 rev. 1 software for models ex1100 and ex1150 merlin@home transmitters; and model mn5000 version 7. 1 software for the merlin. Net system.
Approval Order Approval Order