|
Device | LIVEWIRE TC CARDIAC ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S009 |
Date Received | 02/12/2003 |
Decision Date | 03/28/2003 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISED INDICATIONS FOR USE FOR THESE MODELS OF LIVEWIRE TC ABLATION CATHETERS: 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH UNIVERSAL SENSOR (MODELS 402205-402208); 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH THERMISTOR (MODELS 402209-402212); 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH THERMOCOUPLE (MODELS 402213-402216); 4MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETHER WITH THERMISTOR (MODELS 402229-402232); AND 4MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER XLS WITH THERMISTOR (MODELS 402233-402236). THE CATHETERS ARE INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS. |