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CHILLI II COOLED ABLATION CATHETERS

FDA premarket approval P980003/S007 · decided 2003-09-02

Approval details

PMA number
P980003
Supplement
S007
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CHILLI II COOLED ABLATION CATHETERS
Generic name
Cardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp
Date received
2003-05-14
Decision date
2003-09-02
Days to decision
111 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
San Jose, CA
Statement
APPROVAL FOR THE CHILLI II COOLED ABLATION CATHETER. THE DEVICE IS INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING; DELIVERY DIAGNOSTIC PACING STIMULI; AND RADIOFREQUENCY ABLATION OF MAPPABLE VENTRICULAR TACHYCARDIAS ATTRIBUTABLE TO ISCHEMIC HEART DISEASE OR CARDIOMYOPATHY IN PATIENTS WHO HAVE FAILED DRUG THERAPY.

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510(k) clearances by this applicant

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EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
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