PMA P990025S011

Device: QWIKSTAR NAVIGATION/ABLATION CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S011
Product code: LPB
Decision date: 2006-03-28
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
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.

Current openFDA PMA Record#

Device: QWIKSTAR NAVIGATION/ABLATION CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S011
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2006-03-28
Decision code: APPR
Date received: 2006-01-18
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.