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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 FAMILY CRT-DS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS088
Date Received05/09/2008
Decision Date06/24/2008
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR MINOR MODIFICATIONS AND STANDARDIZATION OF THE GROUND CONNECTION, OUTPUT FLEX, HEAT SHIELD, AND BATTERY SUPPORT FOR ATLA, ATLAS II, CONVERT, CURRENT, EPIC, EPIC II, AND PROMOTE CRT-D AND ICD FAMILIES.
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