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remede System

by Respicardia United States PMA

PMA P160039

Product code PSR

Overview

The remede System is an implantable phrenic nerve stimulator indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients. It is designed to stimulate the phrenic nerve to restore normal breathing patterns during sleep.

The system is supplied as an implantable device and is intended for use in clinical settings under physician supervision. It has received FDA PMA approval (P160039) and is manufactured by Respicardia in Minnetonka, MN. The device is classified as a Class III medical device under the generic name 'Implanted phrenic nerve stimulator for central sleep apnea'.

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 NumberP160039 Date6 Oct 2017ApprovedStatusActive

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 America
  • Active
  • Not covered

United States — FDA PMA Active

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

Specification

PMA · synced 6 Oct 2026

Generic Name
Implanted phrenic nerve stimulator for central sleep apnea
PMA Number
FDA Product Code
PSR
Device Class
Class III
Advisory Committee
Anesthesiology
FDA Decision
APPR Approved

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Questions

  • What is the remede System indicated for?

    The remede System is indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients, as stated in the approval documentation and device specifications.

  • Who manufactures the remede System and where is it located?

    The remede System is manufactured by Respicardia, which is located in Minnetonka, Minnesota, as provided in the manufacturer and address details.

  • What type of regulatory authorization does the remede System have?

    The remede System has received FDA PMA (Premarket Approval) authorization, as explicitly listed in the AUTHORIZATIONS field and confirmed by the PMA number P160039 and decision date.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P160039 24 fields · synced 6 Oct 2026