Ep Technologies EPT-1000 XP RF Ablation System

FDA premarket approval P020025 · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

PMA numberP020025

Approval

Applicant
Boston Scientific
Received
June 24, 2002
Decision date
August 25, 2003 (APPR)
Supplements
141, latest October 17, 2025
Product code
OAD – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Official FDA PMA record

Approval order statement

APPROVAL FOR THE EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM. THE BLAZER II XP CARDIAC ABLATION CATHETER IS INDICATED FOR USE WITH THE EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES FOR THE TREATMENT OF SUSTAINED OR RECURRENT TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES ARE INDICATED FOR USE IN CONJUNCTION WITH STANDARD AND HIGH POWER CATHETERS FOR CARDIAC ABLATION PROCEDURES.