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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Boston Scientific Corp.
2710 orchard pkwy.
san jose, CA 95113
PMA NumberP990054
Supplement NumberS004
Date Received04/10/2002
Decision Date06/28/2002
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 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.