Anthem, Allure/RF, Allure Quadra/RF CRT-Ps
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ANTHEM AND FRONTIER II CRT-P'S FDA PMA
- Generic Name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) FDA PMA
Identifiers
- PMA Number
- P030035 FDA PMA
- FDA Product Code
- NKE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
This device is an implantable cardiac resynchronization therapy-pacing (CRT-P) system, classified as a pulse generator. It is designed to maintain synchrony between the left and right ventricles in patients who have undergone AV nodal ablation for chronic atrial fibrillation and exhibit NYHA Class II or III heart failure. The device delivers synchronized pacing to improve ventricular coordination and cardiac function in eligible patients.
The Anthem, Allure/RF, and Allure Quadra/RF CRT-Ps are single-use, implantable devices intended for surgical implantation by qualified healthcare professionals. They are not MRI-safe and require sterile handling prior to use. Each model is identified by distinct reference codes and is regulated under FDA Premarket Approval (PMA) P030035, with device class III classification. Storage and handling must comply with manufacturer guidelines to ensure device integrity and patient safety.
Frequently asked questions
What specific patient population is the Anthem/Allure/RF CRT-P system designed to support?
This device is intended for patients who have undergone AV nodal ablation due to chronic atrial fibrillation and exhibit NYHA Class II or III heart failure. It is designed to maintain synchrony between the left and right ventricles through synchronized pacing to improve ventricular coordination and cardiac function in eligible patients.
Are these devices reusable or single-use, and what does that mean for surgical planning?
The Anthem, Allure/RF, and Allure Quadra/RF CRT-P systems are **single-use** devices, meaning they are intended for one-time surgical implantation only. This requires careful planning to ensure the correct model is available preoperatively, as reuse is not permitted. Sterile handling is mandatory before use.
How should these devices be stored, and what precautions must be taken?
Storage and handling must strictly follow the manufacturer’s guidelines to maintain device integrity and patient safety. Since these are **single-use, implantable devices**, they should be stored in a way that preserves sterility and prevents contamination. Improper storage could compromise functionality or sterility, so adherence to Abbott Medical’s protocols is essential.
Can these devices be used in patients who require MRI scans, and why?
No, these devices are **not MRI-safe**. They are designed for surgical implantation and are not compatible with MRI procedures, which could pose risks to the patient or damage the device. Clinicians must ensure alternative imaging modalities are used for patients with these implanted systems.
What regulatory pathway was followed for approval, and how does that affect clinical use?
The Anthem, Allure/RF, and Allure Quadra/RF CRT-P systems were approved under **FDA Premarket Approval (PMA) P030035**, a rigorous process for Class III devices. This means the device underwent thorough clinical evaluation to demonstrate safety and effectiveness for its intended use in maintaining ventricular synchrony in patients with chronic atrial fibrillation and NYHA Class II or III heart failure. Clinicians should confirm the device’s approval status and compliance with current guidelines before use.
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. Sources consulted: Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps, Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps… - FDA.report, PDF Allure™, Allure™ RF, Allure Quadra™, Allure Quadra™ RF, Anthem™, Anthem ..., Premarket Approval (PMA)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P030035 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P030035 24 fields · synced Sep 18, 2026