Webster Diag./Ablation Deflectable Tip Catheter

FDA premarket approval P950005 · Cardiac ablation percutaneous catheter

PMA numberP950005

Approval

Applicant
Biosense Webster, Inc.
Received
April 3, 1995
Decision date
September 30, 1997 (APPR)
Supplements
86, latest February 26, 2025
Product code
LPB – Cardiac Ablation Percutaneous Catheter

Official FDA PMA record

Approval order statement

Approval for the Cordis Webster Diagnostic/Ablation Deflectable Tip Catheter. This device includes the following models: six curve types (A, B, C, D, E, and F); tip electrode (4mm tip large and grooved); connector type [Redel 10-pin connector (temperature sensing version) and Nexus plug (non-temperature-sensing version)]; spacing [standard 2-5-2 spacing (center to center measurement of ring electrode spacing)]. This device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) condution pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia; and, creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.