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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.
 
DeviceVARIOUS FAMILIES OF EPIC, ATLAS, PROMOTE, UNIFY CRT-D'S
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS218
Date Received02/22/2012
Decision Date04/13/2012
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 IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS.
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