Therapy Cool Path Duo/ Safire Blu Duo Ablation Catheter and Ibi 1500T9-CP V1.6 Cardiac Ablation Generator

FDA premarket approval P110016 · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

PMA numberP110016

Approval

Applicant
Abbott Medical
Received
April 15, 2011
Decision date
January 25, 2012 (APPR)
Supplements
91, latest August 7, 2026
Product code
OAD – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Official FDA PMA record

Approval order statement

APPROVAL FOR THE THERAPY COOL PATH DUO ABLATION CATHETER; SAFIRE BLU DUO ABLATION CATHETER; AND IBI 1500T-9 VI.6 CARDIAC ABLATION GENERATOR. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMPAND 1500T9-CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.