Safire™ TX Ablation Catheter, Safire™ TX, Catheter Extension Cable, Therapy™ Du…
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER FDA PMA
- Generic Name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter FDA PMA
Identifiers
- PMA Number
- P040042 FDA PMA
- FDA Product Code
- OAD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
This device is a catheter, percutaneous, cardiac ablation, for treatment of atrial flutter, designed to deliver controlled thermal energy to the heart tissue. It is used to create precise lesions that interrupt abnormal electrical pathways responsible for atrial flutter, a type of irregular heartbeat. The system includes an ablation catheter and extension cables to facilitate targeted treatment during cardiac procedures.
The Therapy Dual-8 Cardiac Ablation System is supplied as a sterile, single-use device intended for use in electrophysiology laboratories under fluoroscopic guidance. It is classified as a Class III medical device under FDA regulations and requires professional medical supervision. The system includes various cable configurations (e.g., Cables 16-17-1) to accommodate different procedural needs, and its use is authorized under PMA number P040042 for the specified indication.
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 | P040042 | Class III | Active |
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Manufacturer
- Manufacturer
- Irvine Biomedical, Inc.(Ibi)
- FDA Applicant
- Irvine Biomedical,Inc.(Ibi)
Sources (1)
- FDA PMA P040042 24 fields · synced Oct 6, 2026