Blazer Open-Irrigated Ablation Catheter

FDA premarket approval P150005 · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

PMA numberP150005

Approval

Applicant
Boston Scientific Corp
Received
February 2, 2015
Decision date
February 24, 2016 (APPR)
Supplements
91, latest December 5, 2025
Product code
OAD – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Official FDA PMA record

Approval order statement

Approval for the Blazer Open-Irrigated Ablation Catheter, when used with a Maestro 4000 Radiofrequency (RF) Controller and MetriQ Irrigation Pump, is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent Type I Atrial Flutter (AFL) in patients age 18 or older.