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Stimulator, Spinal-Cord, Totally Implanted For Pain Relief - Class III

FDA PMA

Class III (US FDA PMA)

PMA P210037

by Biotronik Nro, Inc.

Identity

Trade Name
Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management FDA PMA
Generic Name
Stimulator, spinal-cord, totally implanted for pain relief FDA PMA

Identifiers

PMA Number
P210037 FDA PMA
FDA Product Code
LGW FDA PMA
Models / Variants
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief FDA PMA
Class III FDA PMA
Prospera SCS System FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Neurology FDA PMA
FDA Decision
APPR Approved FDA PMA

The Prospera Spinal Cord Stimulation System is a Stimulator, Spinal-Cord, Totally Implanted for Pain Relief, classified as a Class III medical device. It delivers electrical impulses to the spinal cord to modulate pain signals, targeting chronic, intractable pain in the trunk and limbs resulting from conditions such as failed back surgery syndrome, radiculopathy, herniated discs, or complex regional pain syndrome.

This system is implanted surgically and consists of a pulse generator, percutaneous leads, and optional remote management capabilities. It is intended for reusable components, with leads designed for percutaneous insertion. The device operates under FDA_PMA authorization (P210037) and is regulated under product code LGW. Sterility and MRI safety specifications are not detailed in the provided data, but the system requires professional implantation and maintenance in clinical settings.

Frequently asked questions

What types of chronic pain conditions is the Prospera SCS System specifically designed to help manage?

The Prospera Spinal Cord Stimulation System is designed to aid in managing chronic, intractable pain in the trunk and limbs caused by specific conditions such as failed back surgery syndrome, radiculopathy, herniated discs, post-laminectomy pain, complex regional pain syndrome (CRPS), and other related degenerative or post-surgical pain syndromes. It targets pain that has not responded to conservative or surgical treatments.

How is the Prospera SCS System implanted, and what components are involved?

The Prospera SCS System is surgically implanted and consists of a pulse generator (implanted under the skin) and percutaneous leads (threaded into the spinal column). The system delivers electrical impulses to modulate pain signals, and it includes optional remote management capabilities for patient monitoring and adjustments. The leads are designed for percutaneous insertion, meaning they are inserted through the skin into the spinal cord.

Are the components of the Prospera SCS System reusable, and if so, how should they be handled?

Yes, the components of the Prospera SCS System are designed for reuse. However, proper sterilization and maintenance protocols must be followed as per clinical guidelines to ensure patient safety and device functionality. The system requires professional implantation and ongoing clinical oversight.

What regulatory pathway does the Prospera SCS System follow, and what does this mean for clinicians?

The Prospera SCS System follows the FDA Pre-Market Approval (PMA) pathway, authorized under PMA number P210037. This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use. Clinicians should confirm compliance with FDA guidelines and manufacturer instructions for use when prescribing or managing patients with this system.

Does the Prospera SCS System include remote monitoring capabilities, and if so, what are they used for?

Yes, the Prospera SCS System includes optional HomeStream Remote Management capabilities. These features allow clinicians to remotely monitor the device’s performance, adjust stimulation parameters, and track patient progress, improving patient care and reducing the need for in-person visits.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Biotronik Nro, Inc.

Sources (1)

  • FDA PMA P210037 24 fields · synced Sep 18, 2026