|
Device | Blazer and IntellaNav/MiFi Open-Irrigated Ablation Catheters |
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 | S083 |
Date Received | 01/23/2024 |
Decision Date | 03/25/2024 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement request to terminate the INTERRUPT AF Post-Approval Study earlier than planned, with a commitment to provide all available data to the FDA in a final study report |