Pulsed field ablation
FDA decisions under product codes QZI, as the FDA record prints them, with the owning organisation and the Health Canada licence the registry pairs to the decision. 6 decisions.
| Device (FDA record) | Owner | FDA decision | Health Canada licence |
|---|---|---|---|
| PulseSelect™ Pulsed Field Ablation (PFA) systemMedtronic, Inc. | Medtronic | PMA 2023-12-13P230017 · JSON · ArrHub record | 110572 2023-12-13MDALL · JSON |
| FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, (truncated in the FDA record)Farapulse, Inc. | Boston Scientific | PMA 2024-01-30P230030 · JSON · ArrHub record | 111047 2024-04-04MDALL · JSON |
| Sphere-9 Catheter and Affera Ablation SystemMedtronic, Inc. | Medtronic | PMA 2024-10-24P240013 · JSON · ArrHub record | 115505 2026-06-03MDALL · JSON |
| VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)Biosense Webster, Inc. | Johnson & Johnson | PMA 2024-11-06P240006 · JSON · ArrHub record | 111495 2024-07-11MDALL · JSON |
| Globe® Pulsed Field SystemKardium, Inc. | Kardium | PMA 2025-08-27P240044 · JSON · ArrHub record | 115863 2026-07-29MDALL · JSON |
| Volt™ PFA SystemABBOTT MEDICAL | Abbott | PMA 2025-12-19P250022 · JSON · ArrHub record | 115142 2026-04-01MDALL · JSON |
The registry and this page start at 1 January 2019.
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