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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 Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS117
Date Received02/10/2009
Decision Date04/08/2009
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for current/current+ and promote/promote+ devices including current- dr cd2211-36q, current+ vr cd1211-36q, promote + cd3211-36q, current vr cd1207-36q, current dr 2207-36q, and promote cd3207-36q. Additionally, you requested approval to include the devices within an ongoing post approval study, pending final approval by the office of surveillance and biometrics. That post-approval study is being conducted as a condition of approval for p950022/s042, p030054/s067, and p910023/s154.
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