|
Device | CHILLI COOLED ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 2710 ORCHARD PKWY. SAN JOSE, CA 95113 |
PMA Number | P990054 |
Supplement Number | S004 |
Date Received | 04/10/2002 |
Decision Date | 06/28/2002 |
Withdrawal Date
|
07/28/2006 |
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) USE OF A COMPATIBLE RADIOFREQUENCY (RF) GENERATOR FOR DELIVERY OF RF ENERGY THROUGH THE TIP OF THE CHILLI COOLED ABLATION CATHETER AND THE ADDITION OF ACCESSORIES TO CONNECT THE CATHETER TO THE RF GENERATOR; 2) A TEMPERATURE SENSOR CONVERTER (MODEL 2067 THERMOCOUPLE TO THERMISTOR TRANSLATOR (TTT) MODULE) FOR THE THERMOCOUPLE OUTPUT OF THE CHILLI COOLED ABLATION CATHETER TO THE THERMISTOR INPUT OF THE COMPATIBLE RF GENERATOR; AND 3) A SEPARATE, COMPATIBLE PUMP (MODEL 8005 PUMP SYSTEM) FOR DELIVERY OF FLUID FLOW THROUGH THE TIP OF THE CHILLI/COOLED ABLATION CATHETER AND A NEW TUBING KIT ACCESSORY (MODEL 2104 STERILE DISPOSABLE TUBE SET) WHICH CONNECTS THE CATHETER TO THE PUMP. |