HeartLight Endoscopic Ablation System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM FDA PMA
- Generic Name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation FDA PMA
Identifiers
- PMA Number
- P150026 FDA PMA
- FDA Product Code
- OAE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The HeartLight Endoscopic Ablation System is a catheter, percutaneous, cardiac ablation device for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. It is designed to provide endoscopic visualization during ablation procedures to improve treatment accuracy.
The system is manufactured by Cardiofocus, Inc. and has received FDA PMA approval. It is intended for use in clinical settings by trained medical professionals. The device is not described as single-use or reusable in the provided data, and no specific MRI safety information is available.
Frequently asked questions
What is the HeartLight Endoscopic Ablation System used for?
The HeartLight Endoscopic Ablation System is specifically indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. It is a cardiac ablation catheter that provides endoscopic visualization during procedures to enhance treatment precision for this specific cardiac condition.
What regulatory approvals does the HeartLight System have?
The HeartLight Endoscopic Ablation System has received FDA PMA (Pre-market Approval) with the application number P150026. This approval was granted on April 1, 2016, following a review by the Cardiovascular advisory committee, indicating it meets the FDA's safety and effectiveness requirements for its intended use.
Is the HeartLight System reusable or single-use?
The provided data does not specify whether the HeartLight Endoscopic Ablation System is designed for single-use or multiple uses. This information would typically be found in the device's instructions for use, which are not included in the provided specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150026 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiofocus, Inc.
Sources (1)
- FDA PMA P150026 24 fields · synced Sep 18, 2026