Identity
- Trade Name
- OPTIMIZER Smart System FDA PMA
- Generic Name
- Implantable pulse generator FDA PMA
Identifiers
- PMA Number
- P180036 FDA PMA
- FDA Product Code
- QFV FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Optimizer Smart Mini IPG is an implantable pulse generator classified as a Class III medical device under the FDA’s nomenclature. It delivers Cardiac Contractility Modulation (CCM) therapy to improve functional status, 6-minute walk distance, and quality of life in NYHA Class III heart failure patients with a left ventricular ejection fraction between 25% and 45%, who remain symptomatic despite guideline-directed medical therapy and are ineligible for Cardiac Resynchronization Therapy.
This device is implanted subcutaneously and is intended for use in patients in normal sinus rhythm. It is supplied as a single-use, sterile implantable system and requires no external power source beyond the included Guardio/Vesta Charger for battery maintenance. The Optimizer Smart Mini IPG is authorized under FDA PMA (P180036) and is designed for cardiovascular applications, adhering to strict regulatory standards for Class III devices.
Frequently asked questions
What specific patient population is the Optimizer Smart Mini IPG designed to treat, and what criteria must they meet?
The Optimizer Smart Mini IPG is designed for NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy. Eligible patients must be in normal sinus rhythm, ineligible for Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction between 25% and 45%. It delivers Cardiac Contractility Modulation (CCM) therapy to improve functional status, 6-minute walk distance, and quality of life.
How is the Optimizer Smart Mini IPG powered, and what accessories are required for its maintenance?
The Optimizer Smart Mini IPG is implanted subcutaneously and does not require an external power source beyond the included **Guardio/Vesta Charger**, which is used for battery maintenance. The device itself is a standalone, single-use implantable system.
Is the Optimizer Smart Mini IPG reusable, or is it intended for single-use only?
The Optimizer Smart Mini IPG is supplied as a **single-use, sterile implantable system**, meaning it is designed for one-time implantation and is not intended for reuse.
What regulatory pathway was followed for FDA authorization of this device, and what does that mean for its use?
The Optimizer Smart Mini IPG was authorized under the **FDA Premarket Approval (PMA) process**, specifically under PMA number **P180036**. This pathway is reserved for high-risk, Class III devices, ensuring rigorous evaluation of safety and effectiveness before approval. Clinicians and buyers can rely on this authorization as evidence of the device’s compliance with strict regulatory standards for cardiovascular applications.
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: PDF OPTIMIZER Smart Mini System Patient's Manual - impulse-dynamics.com, PDF OPTIMIZER® Smart Mini Implantable Pulse Generator - Impulse Dynamics, Impulse Dynamics OPTIMIZER Smart Mini Patient Manual, Impulse Dynamics OPTIMIZER Smart Mini Instructions For Use Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180036 | Class III | Active |
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Manufacturer
- Manufacturer
- Impulse Dynamics (usa) Inc.
- FDA Applicant
- Impulse Dynamics (Usa), Inc.
Sources (1)
- FDA PMA P180036 24 fields · synced Sep 18, 2026