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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS065
Date Received02/07/2003
Decision Date04/23/2003
Product Codes DXY LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE EPIC PLUS DR/VR DEVICE WITH MODEL 3307 VERSION 4.3A PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-196 AND V-236) AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION. THE PROGRAMMER SOFTWARE MODEL 3307 VERSION 4.3A SUPPORTS ST. JUDE MEDICAL'S BRADYCARDIA AND TACHYCARDIA PULSE GENERATORS.
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