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FDA PMA

Shockwave intravascular lithotripsy system

PMA Number: P200039 · 2026-05-07

ApplicantShockwave Medical, Inc.
Decision Date2026-05-07
PMA NumberP200039
Product CodeQMG
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Shockwave intravascular lithotripsy system is a medical device manufactured by Shockwave Medical, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-07 under PMA number P200039. The device is classified under FDA product code QMG. 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 Shockwave intravascular lithotripsy system?

Shockwave intravascular lithotripsy system is a medical device that received FDA Premarket Approval (PMA) on 2026-05-07. It is manufactured by Shockwave Medical, Inc.. The PMA number is P200039.

When did Shockwave intravascular lithotripsy system receive FDA PMA approval?

Shockwave intravascular lithotripsy system received FDA PMA approval on 2026-05-07, under approval number P200039.

What company makes Shockwave intravascular lithotripsy system?

Shockwave intravascular lithotripsy system is manufactured by Shockwave Medical, 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 Shockwave intravascular lithotripsy system?

The FDA product code for Shockwave intravascular lithotripsy system is QMG.

What FDA device class is Shockwave intravascular lithotripsy system?

Shockwave intravascular lithotripsy system 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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