PMA supplement
P150026 S015: HeartLight Catheter, HeartLight X3 Console V2
FDA PMA supplement · Normal 180 Day Track No User Fee · Cardiofocus, Inc.
Key facts
| Original PMA | P150026 |
|---|---|
| Supplement number | S015 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HeartLight Catheter, HeartLight X3 Console V2 |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | Cardiofocus, Inc. |
| Product code | OAE |
| Received date | Mar 2, 2023 |
| Decision date | Aug 11, 2023 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: