Intica Neo 5 DR-T DF-1 ProMRI, Ilivia Neo 7 DR-T DF-1 ProMRI, Intica Neo 7 DR-T…
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- PHYLAX AV ICD SYSTEM FDA PMA
- Generic Name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER FDA PMA
Identifiers
- PMA Number
- P000009 FDA PMA
- FDA Product Code
- MRM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Intica Neo 5 DR-T DF-1 ProMRI, Intica Neo 7 DR-T DF-1 ProMRI, and Ilivia Neo 7 DR-T DF-1 ProMRI are implantable dual-chamber defibrillators designed to monitor and treat ventricular arrhythmias. These devices deliver both pacing and defibrillation therapies to patients at high risk of sudden cardiac death, including those who have survived cardiac arrest or experienced recurrent, poorly tolerated sustained ventricular tachycardia.
These systems are intended for surgical implantation and are supplied sterile for single-use. Each model includes a pulse generator and associated software cartridge, with MRI compatibility up to 3 Tesla. Storage and handling must comply with sterile medical device protocols, and regulatory approval includes a Premarket Approval (PMA) from the FDA under PMA number P000009. The devices are classified as Class III under the FDA’s regulatory framework.
Frequently asked questions
What types of patients are these devices intended for based on the FDA approval criteria?
These devices are approved for patients at high risk of sudden cardiac death due to ventricular arrhythmias, specifically those who have survived at least one episode of cardiac arrest caused by ventricular tachyarrhythmia or have experienced recurrent, poorly tolerated sustained ventricular tachycardia. The approval does not extend to hemodynamically stable, sustained-VT patients, as safety and effectiveness studies for this group have not been conducted.
Are these devices MRI-compatible, and if so, what is the maximum MRI strength they can safely withstand?
Yes, these devices are designed with MRI compatibility in mind and can safely withstand MRI scans up to a strength of 3 Tesla. This feature is particularly useful for patients who may require MRI imaging in the future.
How are these devices supplied, and what should be considered regarding their sterility and usage?
The devices are supplied sterile and are intended for single-use only. They must be handled according to sterile medical device protocols to ensure patient safety and device integrity. The sterile packaging ensures they are ready for surgical implantation without additional sterilization.
What regulatory pathway was followed for FDA approval of these devices, and what classification do they hold?
These devices followed the Premarket Approval (PMA) pathway, which is required for Class III medical devices due to their high-risk nature. The FDA granted approval under PMA number P000009, confirming their safety and effectiveness for the specified indications. Class III classification is reserved for devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.
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 | P000009 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA PMA P000009 24 fields · synced Sep 18, 2026