PSRClass III

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

Unknown

PSR is the FDA product code for Implanted Phrenic Nerve Stimulator For Central Sleep Apnea, a class III device type. FDA's definition for this code reads: "The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PSR
Device name: Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA definition: The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PSR

FDA records hold no clearances under product code PSR.

Recent recalls

Product code PSR

FDA records show no recalls under product code PSR.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)