|
Device | Blazer II Cardiac Ablation Catheter and Cable |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S111 |
Date Received | 08/24/2018 |
Decision Date | 09/19/2018 |
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 Introduction of an approved sterilization cycle in Chamber 4 of the Costa Rica facility. |