Identity
- Trade Name
- MAGiC Ablation Catheter FDA PMA
- Generic Name
- Cardiac ablation percutaneous catheter FDA PMA
Identifiers
- PMA Number
- P240014 FDA PMA
- FDA Product Code
- LPB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The MAGiC Ablation Catheter is a cardiac ablation percutaneous catheter designed for magnetic navigation. It facilitates cardiac electrophysiological mapping, diagnostic pacing, and the creation of endocardial lesions to treat supraventricular tachycardias in patients with congenital heart disease. Its magnetic guidance system enables precise catheter positioning in anatomically complex or surgically altered chambers where conventional manual navigation is challenging.
This device is supplied as a single-use, non-sterile catheter intended for use in electrophysiology laboratories. It is compatible with MRI environments and requires no special storage conditions beyond standard catheter handling. Authorized under FDA_PMA (PMA Number: P240014), it adheres to Class III regulatory standards for percutaneous cardiac devices. No additional sterility or reprocessing is specified, and its use is restricted to qualified electrophysiologists in controlled clinical settings.
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 | P240014 | Class III | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA PMA P240014 24 fields · synced Sep 18, 2026