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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 NameST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS
Classification Namepulse generator, permanent, implantable
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS128
Date Received11/30/2006
Decision Date12/14/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) an alternate electrolyte (tm422) in the high voltage capacitor used in the st. Jude medical epic dr/vr/hf, epic+ dr/vr and epic ii/ii + dr/vr/hf devices; and 2) the minor modifications to the crystal tuning fork used in epic, epic+, epic ii/ii +, atlas, atlas+, atlas ii/ii + devices.
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