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FDA PMA

Transvenous temporary phrenic nerve stimulator

PMA Number: P240012 · 2026-06-22

ApplicantLungpacer Medical USA, Inc.
Decision Date2026-06-22
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 PMA record. The listed applicant is Lungpacer Medical USA, Inc.. It received FDA Premarket Approval (PMA) on 2026-06-22 under PMA number P240012. The device is classified under FDA product code SDL. It was reviewed by the AN advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Transvenous temporary phrenic nerve stimulator?

Transvenous temporary phrenic nerve stimulator is a medical device that received FDA Premarket Approval (PMA) on 2026-06-22. The listed applicant is Lungpacer Medical USA, Inc.. The PMA number is P240012.

When did Transvenous temporary phrenic nerve stimulator receive FDA PMA approval?

Transvenous temporary phrenic nerve stimulator received FDA PMA approval on 2026-06-22, under PMA number P240012.

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

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

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

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

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

What FDA device class is Transvenous temporary phrenic nerve stimulator?

Transvenous temporary phrenic nerve stimulator is classified as Class III by the FDA.

Official Source

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

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