Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA

Implanted phrenic nerve stimulator for central sleep apnea

PMA Number: P160039 · 2025-05-07

ApplicantRespicardia
Decision Date2025-05-07
PMA NumberP160039
Product CodePSR
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

Implanted phrenic nerve stimulator for central sleep apnea is the device name listed in this FDA 510(k) record. The listed applicant is Respicardia. It received FDA 510(k) clearance on 2025-05-07. The device is classified under product code PSR. It was reviewed by the AN advisory panel.

Frequently Asked Questions

What is the Implanted phrenic nerve stimulator for central sleep apnea?

Implanted phrenic nerve stimulator for central sleep apnea is a medical device that received FDA 510(k) clearance on 2025-05-07. The listed applicant is Respicardia.

When did Implanted phrenic nerve stimulator for central sleep apnea receive FDA 510(k) clearance?

The clearance date for Implanted phrenic nerve stimulator for central sleep apnea can be found in the official FDA records.

Who is the listed applicant for Implanted phrenic nerve stimulator for central sleep apnea?

The FDA 510(k) record lists Respicardia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implanted phrenic nerve stimulator for central sleep apnea?

The FDA product code for Implanted phrenic nerve stimulator for central sleep apnea is PSR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑