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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 FAMILY OF CRT-DS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS198
Date Received08/10/2011
Decision Date09/08/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model 3330 version 13. 1 programmer software which includes enhancements to the layout/design of the existing merlin pcs printed reports.
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