|
Device | CHILLI II COOLED ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S013 |
Date Received | 08/30/2004 |
Decision Date | 10/14/2004 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |