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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.
 
DeviceEPIC HF/ATLAS+ HF FAMILY OF CRT-DS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
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/material
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, YOUREQUESTED 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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