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Barostim Neo System

by Cvrx, Inc. United States PMA

PMA P180050 Product code DSR

Overview

The Barostim Neo System is a Stimulator, Carotid Sinus Nerve (per OpenFDA nomenclature), designed to modulate baroreflex activity via electrical stimulation of the carotid sinus nerve. It is classified as a Class III device under FDA regulations (870.3850) and is intended for patients with symptomatic heart failure who remain unstable despite guideline-directed medical therapy.

This system is implanted surgically and is intended for long-term use. It is supplied sterile and requires surgical implantation by a qualified healthcare provider, with no indication of single-use or reusable status. The device is not MRI-safe, and its use is authorized under FDA_PMA (PMA Number: P180050) for the specified patient population. Storage and handling follow standard sterile surgical implant protocols as defined by regulatory guidelines.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP180050 Date16 Aug 2019ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

PMA · synced 6 Oct 2026

Generic Name
Stimulator, carotid sinus nerve
PMA Number
FDA Product Code
DSR
Device Class
Class III
Regulation
21 CFR Part 870.3850
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P180050 24 fields · synced 6 Oct 2026