Chilli Cooled Ablation System

FDA premarket approval P990054 · Cardiac ablation percutaneous catheter

PMA numberP990054

Approval

Applicant
Boston Scientific Corp
Received
September 20, 1999
Decision date
March 17, 2000 (APWD)
Supplements
7, latest June 13, 2006
Product code
LPB – Cardiac Ablation Percutaneous Catheter

Official FDA PMA record

Approval order statement

The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, RF ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy. In addition, the Chilli Catheter with Tracking is used with the Arrhythmia Mapping and Tracking System to provide catheter location information.