|
Device | Blazer Open Irrigated Cardiac Ablation System |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P150005 |
Supplement Number | S075 |
Date Received | 03/30/2023 |
Decision Date | 04/27/2023 |
Product Code |
OAD |
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 Use of parametric release and an alternate process challenge device for the BSC2019 ethylene oxide sterilization cycle at the Steris AST Costa Rica Facility. |