H.E.L.P. System

FDA PMA

Class III (US FDA PMA)

PMA P940016

by B.Braun Avitum AG

Identity

Trade Name: H.E.L.P. SYSTEM FDA PMA
Generic Name: Lipoprotein, low density, removal FDA PMA

Identifiers

PMA Number: P940016 FDA PMA
FDA Product Code: MMY FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Gastroenterology, Urology FDA PMA
FDA Decision: APPR Approved FDA PMA

The H.E.L.P. System is a low density lipoprotein cholesterol (LDL-C) apheresis system manufactured by B. Braun Avitum AG. It is designed to perform LDL-C apheresis to acutely remove low density lipoprotein cholesterol from the plasma of high-risk patient populations.

This device is indicated for patients for whom diet has been ineffective or not tolerated. The system has received FDA PMA authorization for its clinical application in managing cholesterol levels.

Frequently asked questions

What is the primary function of the H.E.L.P. System?

The H.E.L.P. System is an apheresis device specifically designed to remove low density lipoprotein cholesterol (LDL-C) from a patient's plasma.

Who is the intended patient population for this device?

The system is indicated for high-risk patient populations who have not achieved success with dietary interventions or who cannot tolerate dietary management for their cholesterol levels.

Is the H.E.L.P. System authorized for use?

Yes, the device has received FDA PMA authorization, confirming it has met the necessary regulatory requirements for its indicated use in LDL-C apheresis.

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: Premarket Approval (PMA) - FDA, HaRi · Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P. ..., Plasmat Futura Apheresis System from B. Braun - News-Medical, HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN… - FDA ..., Emerging low-density lipoprotein (LDL) therapies

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Pending data

MDR

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	European Union	MDR	—	Class III	Pending data
FDA PMA	United States	FDA_PMA	P940016	Class III	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: B.Braun Avitum AG
FDA Applicant: B. Braun Avitum AG

Sources (1)

FDA PMA P940016 24 fields · synced Sep 18, 2026