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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/ATLAS DR/VR ICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacemaker programmer software
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP910023
Supplement NumberS064
Date Received01/17/2003
Decision Date02/12/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the supplier for the high voltage capacitor cathode material used for the st. Jude medical implantable cardioverter defibrillators.
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