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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 FAMILY OF CRT-DS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS189
Date Received05/02/2011
Decision Date08/03/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for model 3330 programmer software version 10. 1. 2, which includes minor modifications to the pacing lead impedance feature.
Approval Order Approval Order
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