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Device | HELIOS II ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 ST. LOUIS, MO 63108 |
PMA Number | P050029 |
Date Received | 08/23/2005 |
Decision Date | 10/10/2008 |
Product Code |
LPB |
Docket Number | 08M-0601 |
Notice Date | 12/01/2008 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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