FDA PMA

Pulmonary valve prosthesis percutaneously delivered

PMA Number: P140017 · 2026-06-09

ApplicantMedtronic, Inc.

Decision Date2026-06-09

PMA NumberP140017

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 Medtronic, Inc.. It received FDA Premarket Approval (PMA) on 2026-06-09 under PMA number P140017. 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 2026-06-09. The listed applicant is Medtronic, Inc.. The PMA number is P140017.

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

Pulmonary valve prosthesis percutaneously delivered received FDA PMA approval on 2026-06-09, under PMA number P140017.

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

The FDA PMA record lists Medtronic, 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 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.

NCT05077774Harmony TPV Post-Approval StudyACTIVE_NOT_RECRUITING NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITING NCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

Other records listing Medtronic, Inc. as applicant

PMA P960009Stimulator, electrical, implanted, for parkinsonian tremor PMA P860004Pump, infusion, implanted, programmable PMA P130021Aortic valve, prosthesis, percutaneously delivered PMA P240013Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation PMA P100047Ventricular (assist) bypass PMA P980035Pulse generator, permanent, implantable

View all 166 devices →

Related Devices (Code: NPV)

PMA P200015Pulmonary valve prosthesis percutaneously deliveredEdwards Lifesciences, LLC 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.