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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 Namedual chamber implantable cardioverter defibrillator with biventricular pacing
PMA NumberP030054
Supplement NumberS060
Date Received07/19/2007
Decision Date08/17/2007
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate supplier for the isolation transformer module (itm) and toroid inductor used on the high voltage hybrid assembly of the current icds and promote crt-ds.