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CHILLI II COOLED ABLATION CATHETER

FDA premarket approval P980003/S013 · decided 2004-10-14

Approval details

PMA number
P980003
Supplement
S013
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CHILLI II COOLED ABLATION CATHETER
Generic name
Cardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp
Date received
2004-08-30
Decision date
2004-10-14
Days to decision
45 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
San Jose, CA
Statement
APPROVAL FOR CHANGES MADE TO THE INTERNAL DISTAL TIP CONFIGURATION AND THE CATHETER SHAFT AS WELL AS CHANGES IN THE MANUFACTURING PROCESS TO BOND THE STEERING MECHANISM TO THE BRAIDED SHAFT FOR THE CHILLI II CARDIAC ABLATION CATHETER.

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