|
Device | LIVEWIRE TC COMPASS STEERABLE ELECTROPHYSIOLOGY CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S004 |
Date Received | 03/30/2000 |
Decision Date | 06/14/2001 |
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 1 (ONE) YEAR SHELF-LIFE, THE INCORPORATION OF ADDITIONAL ELECTRODES FOR STIMULATION AND MAPPING (10 ELECTRODES TOTAL), AND OTHER MINOR DEVICE MODIFICATIONS. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIVEWIRE TC COMPASS CATHETER AND IS INDICATED FOR USE FOR CARDIAC ELECTROPHYSIOLOGICAL. MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL BLOCK RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETION AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR TO AN ATRIAL ARRHYTHMIA. |