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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.
 
DeviceST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS045
Date Received11/21/2006
Decision Date12/13/2006
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE ICD/CRT-D DEVICE HYBRID: 1) ADDITION OF A NEW C64 MICRO CONTROLLER INTEGRATED CIRCUIT (IC); 2) CHANGES TO THE C46 VSS SUPPLY CAPACITOR FROM 3.3 UF TO 33 UF; AND 3) CHANGES TO DIODES D17, D19 AND D23 IN THE PROTECTION CIRCUIT.
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