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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.
 
DeviceATLAS+ DR/BR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS069
Date Received09/11/2003
Decision Date10/17/2003
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE EPIC+ ICDS TO INCLUDE HIGHER ENERGY OUTPUT, SOFTWARE MODIFICATIONS, AND A DIFFERENT HEADER TYPE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODELS V-242, V-243, V-193 AND V-193C, EPIC+ MODELS V-233, V-239 AND V196, AND MODEL 3307 V.4.5A SOFTWARE, AND IS INTENDED 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 INDICATIONS
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