PMA
P150026: HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation · Cardiofocus, Inc.
Key facts
| PMA number | P150026 |
|---|---|
| Trade name | HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | Cardiofocus, Inc. |
| Owner/operator | CARDIOFOCUS, INC. |
| Product code | OAE |
| Approval date | Apr 1, 2016 |
| Docket number | 16M-1124 |
| Notice date | Apr 12, 2016 |
| Establishment registration | 1225698 |
| FEI number | 3001451473 |
At a glance
- 10–99 Supplements
- Aug 11, 2023 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: