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CHILLI COOLED ABLATION SYSTEM

FDA premarket approval P990054 · decided 2000-03-17

Approval details

PMA number
P990054
Trade name
CHILLI COOLED ABLATION SYSTEM
Generic name
Cardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp
Date received
1999-09-20
Decision date
2000-03-17
Days to decision
179 days
Decision code
APWD
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
San Jose, CA
Statement
The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, RF ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy. In addition, the Chilli Catheter with Tracking is used with the Arrhythmia Mapping and Tracking System to provide catheter location information.

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510(k) clearances by this applicant

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