EXCOR Pediatric Ventricular Assist Device
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- EXCOR Pediatric Ventricular Assist Device FDA PMA
- Generic Name
- Ventricular (assist) bypass FDA PMA
Identifiers
- PMA Number
- P160035 FDA PMA
- FDA Product Code
- DSQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The EXCOR Pediatric Ventricular Assist Device is a Class III mechanical circulatory support system designed as a bridge to cardiac transplantation for pediatric patients. It provides temporary ventricular assist to patients with severe isolated left or biventricular dysfunction who require circulatory support prior to heart transplant.
This device is intended for use in a clinical setting and is approved under an FDA Premarket Approval (PMA) application (P160035). It is supplied as a reusable system with specific cannulae and driveline components tailored for pediatric patients. The device is not single-use and requires proper sterilization and maintenance procedures as outlined in the manufacturer’s instructions. No MRI safety information is specified in the available data.
Frequently asked questions
What is the primary clinical purpose of the EXCOR Pediatric Ventricular Assist Device, and who is it intended for?
The EXCOR Pediatric Ventricular Assist Device is designed to provide temporary mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. It is specifically intended for children with severe isolated left or biventricular dysfunction who require circulatory assistance prior to a heart transplant. The device is not intended for long-term use but serves as a critical interim solution to stabilize patients awaiting transplantation.
Is the EXCOR Pediatric Ventricular Assist Device single-use or reusable, and what maintenance is required?
The EXCOR Pediatric is a reusable system, meaning it is not intended for single-use. Proper sterilization and maintenance procedures must be followed as outlined in the manufacturer’s instructions to ensure safe and effective operation. This includes cleaning, disinfection, and inspection of components like cannulae and drivelines to maintain functionality and reduce infection risk.
What regulatory pathway was followed for approval of the EXCOR Pediatric Ventricular Assist Device, and what does this mean for its use?
The device was approved through the FDA’s Premarket Approval (PMA) process under application number P160035, which is the highest level of regulatory review for Class III medical devices. This approval confirms that the device meets rigorous standards for safety and effectiveness as a bridge-to-transplant solution for pediatric patients with severe heart dysfunction, ensuring it is only used in clinical settings where such support is medically necessary.
Are there specific sizes or models available for the EXCOR Pediatric Ventricular Assist Device, and how does this relate to pediatric patients?
The device is tailored for pediatric patients, with cannulae and driveline components specifically designed for this age group. While the exact sizes or model variations aren’t detailed in the data, the system is engineered to accommodate the smaller physiological requirements of children, ensuring compatibility with pediatric anatomy and circulatory needs during temporary ventricular assist.
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: Patienten und Angehörige EXCOR Adult - Berlin Heart, Berlin Heart – Wikipedia, Medical Professionals EXCOR Adult - Berlin Heart
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160035 | Class III | Active |
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Manufacturer
- Manufacturer
- Berlin Heart, Inc.
Sources (1)
- FDA PMA P160035 24 fields · synced Sep 18, 2026