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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 V-338
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 NumberS031
Date Received06/26/2006
Decision Date07/11/2006
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 THE ST. JUDE MEDICAL ATLAS II/II+ VR/DR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM. THE ATLAS II/II+ DEVICES ARE SUPPORTED BY THE MODEL 3510 PROGRAMMER WITH MODEL 3307 V6.1 (OR HIGHER) PROGRAMMER SOFTWARE OR THE MERLIN PATIENT CARE SYSTEM MODEL 3650 WITH MODEL 3330 V3.0 (OR HIGHER) PROGRAMMER SOFTWARE.
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