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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/ATLAS + HF/PROMOTE/UNIFY FAMILY OF CRT-DS
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS193
Date Received06/28/2011
Decision Date08/17/2011
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor modifications to the patient manuals packaged with the devices.
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