|
Device | QWIKSTAR NAVIGATION/ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990025 |
Supplement Number | S011 |
Date Received | 01/18/2006 |
Decision Date | 03/28/2006 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MINOR LABELING REVISION FOR THE 4 MM QWIKSTAR DIAGNOSTIC/ABLATION CATHETER TO INCLUDE THE NOGA XP NAVIGATION SYSTEM AS AN OPTIONAL MAPPING SYSTEM FOR THE QWIKSTAR CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH COMPATIBLE RADIO-FREQUENCY GENERATORS IN ADULTS AND CHILDREN FOUR YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS. WHEN USED IN THE CARTO XP EP OR NOGA XP NAVIGATION SYSTEMS, THE QWIKSTAR DIAGNOSTIC/ABLATION CATHETER PROVIDES LOCATION INFORMATION AND APPROXIMATE CATHETER TIP CURVATURE. |