CHILLI COOLED ABLATION SYSTEM
FDA premarket approval P990054/S004 · decided 2002-06-28
Approval details
- PMA number
- P990054
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CHILLI COOLED ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2002-04-10
- Decision date
- 2002-06-28
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- 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 SY
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