|
Device | Blazer II XP Cardiac Ablation Catheter and Cable |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BOSTON SCIENTIFIC 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P020025 |
Supplement Number | S126 |
Date Received | 03/12/2020 |
Decision Date | 05/19/2020 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Boston Scientific Corp. in Ballybrit Business Park Galway, Ireland for sterilization. |