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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceHELIOS II ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantSTEREOTAXIS, INC.
4320 FOREST PARK AVENUE
SUITE 100
ST. LOUIS, MO 63108
PMA NumberP050029
Date Received08/23/2005
Decision Date10/10/2008
Product Code LPB 
Docket Number 08M-0601
Notice Date 12/01/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE HELIOS II ABLATION CATHETER. THE HELIOS II ABLATION CATHETER IS INTENDED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING, DELIVERING DIAGNOSTIC PACING STIMULI, AND FOR THE CREATION OF ENDOCARDIAL LESIONS TO TREAT PATIENTS WITH SUPRAVENTRICULAR (SVT) TACHYCARDIAS.IT IS INTENDED TO ELIMINATE ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) IN PATIENTS WITH OVERT OR CONCEALED ACCESSORY PATHWAYS, TO ELIMINATE AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT), AND TO CREATE COMPLETE AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO ATRIAL FIBRILLATION.THE HELIOS II ABLATION CATHETER IS INTENDED FOR USE WITH THE BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR VIA A BIOSENSE WEBSTER CABLE MODEL C6-MR10/MSTK-S (6 FOOT) OR C10-MR10/MSTK-S (10 FOOT). THE HELIOS II ABLATION CATHETER IS FOR USE ONLY WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS) AND IS COMPATIBLE WITH THE CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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