|
Device | CHILLI II COOLED ABLATION CATHETER AND CABLE |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S042 |
Date Received | 09/19/2013 |
Decision Date | 10/18/2013 |
Withdrawal Date
|
02/28/2024 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY. |