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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 NameEPIC HF FAMILY CRT-DS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS122
Date Received04/02/2009
Decision Date05/07/2009
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) replacing the existing hand solder interconnections between subassemblies with plug/receptacle connectors, epoxy, direct solder or laser welding. 2) using an organic substrate for the hybrid module. 3) reconfiguring discrete surface mount magnetic components (e. G. Hv converter board assembly, sensor support assembly) to integrate them into the hybrid.
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