|
Device | CHILLI II COOL ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S038 |
Date Received | 07/05/2013 |
Decision Date | 08/28/2013 |
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 A MATERIAL CHANGE TO AN ALREADY KNOWN MATERIAL FOR YOUR SOLDER AND FLUX. |