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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEPIC HF CRT-DS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS060
Date Received07/19/2007
Decision Date08/17/2007
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
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.
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