|
Device | CHILLI II COOLED ABLATION CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S007 |
Date Received | 05/14/2003 |
Decision Date | 09/02/2003 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHILLI II COOLED ABLATION CATHETER. THE DEVICE IS INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING; DELIVERY DIAGNOSTIC PACING STIMULI; AND RADIOFREQUENCY ABLATION OF MAPPABLE VENTRICULAR TACHYCARDIAS ATTRIBUTABLE TO ISCHEMIC HEART DISEASE OR CARDIOMYOPATHY IN PATIENTS WHO HAVE FAILED DRUG THERAPY. |