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FDA PMA

Implantable pulse generator

PMA Number: P180036 · 2026-05-13

ApplicantImpulse Dynamics (Usa), Inc.
Decision Date2026-05-13
PMA NumberP180036
Product CodeQFV
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Implantable pulse generator is a medical device manufactured by Impulse Dynamics (Usa), Inc.. It received FDA Premarket Approval (PMA) on 2026-05-13 under PMA number P180036. The device is classified under FDA product code QFV. It was reviewed by the CV 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 the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. 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 Implantable pulse generator?

Implantable pulse generator is a medical device that received FDA Premarket Approval (PMA) on 2026-05-13. It is manufactured by Impulse Dynamics (Usa), Inc.. The PMA number is P180036.

When did Implantable pulse generator receive FDA PMA approval?

Implantable pulse generator received FDA PMA approval on 2026-05-13, under approval number P180036.

What company makes Implantable pulse generator?

Implantable pulse generator is manufactured by Impulse Dynamics (Usa), Inc..

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 the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Implantable pulse generator?

The FDA product code for Implantable pulse generator is QFV.

What FDA device class is Implantable pulse generator?

Implantable pulse generator 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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