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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-D'S
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS073
Date Received10/22/2007
Decision Date12/19/2007
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 the following modifications: 1) replace the existing hand solder interconnections between subassemblies with plug/receptacle connectors; 2) an organic substrate will be used for the hybrid module; and 3) discrete surface mount magnetic components were re-configured into surface-mountable packages.
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