FDA PMA

Transvenous temporary phrenic nerve stimulator

Numéro PMA : P240012 · 2026-09-25

DemandeurLungpacer Medical USA, Inc.

Date de décision2026-09-25

Numéro PMAP240012

Code produitSDL

Classe de dispositifClasse 3

Spécialité médicaleU

Comité consultatifAN

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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