|
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 | S019 |
Date Received | 05/10/2007 |
Decision Date | 07/24/2007 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENSION OF THE EXPIRATION DATE (SHELF-LIFE) FROM ONE-YEAR TO THREE-YEARS FOR THE CHILLI II CARDIAC ABLATION CATHETER. |