|
Device | CHILLI COOLED ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S041 |
Date Received | 09/09/2013 |
Decision Date | 10/07/2013 |
Withdrawal Date
|
02/28/2024 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR IEC 60601-1 3RD EDITION LABELING IMPLEMENTATION TO THE BLAZER II, BLAZER II XP/HTD, BLAZER PRIME XP/HTD AND CHILLI II CARDIAC ABLATION CATHETERS AND CABLES. |