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FDA PMA

Transvenous temporary phrenic nerve stimulator

PMA Number: P240012 · 2026-09-25

ApplicantLungpacer Medical USA, Inc.
Decision Date2026-09-25
PMA NumberP240012
Product CodeSDL
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

Transvenous temporary phrenic nerve stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Lungpacer Medical USA, Inc.. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code SDL. It was reviewed by the AN advisory panel.

Frequently Asked Questions

What is the Transvenous temporary phrenic nerve stimulator?

Transvenous temporary phrenic nerve stimulator is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Lungpacer Medical USA, Inc..

When did Transvenous temporary phrenic nerve stimulator receive FDA 510(k) clearance?

The clearance date for Transvenous temporary phrenic nerve stimulator can be found in the official FDA records.

Who is the listed applicant for Transvenous temporary phrenic nerve stimulator?

The FDA 510(k) record lists Lungpacer Medical USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transvenous temporary phrenic nerve stimulator?

The FDA product code for Transvenous temporary phrenic nerve stimulator is SDL.

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.

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