FDA PMA

Pulmonary valve prosthesis percutaneously delivered

PMA Number: P200015 · 2026-07-29

ApplicantEdwards Lifesciences, LLC

Decision Date2026-07-29

PMA NumberP200015

Product CodeNPV

Device ClassClass f

Medical SpecialtyU

Advisory CommitteeCV

Device Summary

Pulmonary valve prosthesis percutaneously delivered is the device name listed in this FDA PMA record. The listed applicant is Edwards Lifesciences, LLC. It received FDA Premarket Approval (PMA) on 2026-07-29 under PMA number P200015. The device is classified under FDA product code NPV. It was reviewed by the CV advisory panel. 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 Pulmonary valve prosthesis percutaneously delivered?

Pulmonary valve prosthesis percutaneously delivered is a medical device that received FDA Premarket Approval (PMA) on 2026-07-29. The listed applicant is Edwards Lifesciences, LLC. The PMA number is P200015.

When did Pulmonary valve prosthesis percutaneously delivered receive FDA PMA approval?

Pulmonary valve prosthesis percutaneously delivered received FDA PMA approval on 2026-07-29, under PMA number P200015.

Who is the listed applicant for Pulmonary valve prosthesis percutaneously delivered?

The FDA PMA record lists Edwards Lifesciences, LLC 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 Pulmonary valve prosthesis percutaneously delivered?

The FDA product code for Pulmonary valve prosthesis percutaneously delivered is NPV.

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.

NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITING NCT05006404Autus Valve Pivotal StudyACTIVE_NOT_RECRUITING NCT07466745Autus Valve Continued Access Study (CAS)RECRUITING NCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITING NCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITING NCT03745313Edwards CLASP TR EFSCOMPLETED

Other records listing Edwards Lifesciences, LLC as applicant

PMA P230013Percutaneously Delivered Prostheses and Tricuspid Valves PMA P860057replacement Heart-valve PMA P250019Prosthesis, mitral valve, percutaneously delivered PMA P220003Mitral valve repair devices PMA P150048heart-valve, non-allograft tissue PMA P150036heart-valve, non-allograft tissue

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Related Devices (Code: NPV)

PMA P140017Pulmonary valve prosthesis percutaneously deliveredMedtronic, Inc.PMA P200046Pulmonary valve prosthesis percutaneously deliveredMedtronic, Inc.

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.