Ablation catheters
FDA decisions under product codes LPB, OAD, OAE, as the FDA record prints them, with the owning organisation and the Health Canada licence the registry pairs to the decision. 4 decisions.
| Device (FDA record) | Owner | FDA decision | Health Canada licence |
|---|---|---|---|
| QDOT MICRO™ SystemBiosense Webster, Inc. | Johnson & Johnson | PMA 2022-11-23P210027 · JSON · ArrHub record | No licence as at 14 October 2026 |
| TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C (truncated in the FDA record)ABBOTT MEDICAL | Abbott | PMA 2023-05-18P220013 · JSON · ArrHub record | No licence as at 14 October 2026 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, AccessoriesBoston Scientific Corporation | Not resolved | PMA 2023-08-08P220032 · JSON · ArrHub record | No licence as at 14 October 2026 |
| MAGiC Ablation CatheterStereotaxis, Inc. | Stereotaxis | PMA 2026-01-05P240014 · JSON · ArrHub record | No licence as at 14 October 2026 |
The registry and this page start at 1 January 2019.
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