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FDA PMA

Pulmonary valve prosthesis percutaneously delivered

PMA Number: P200015 · 2020-12-18

ApplicantEdwards Lifesciences, LLC
Decision Date2020-12-18
PMA NumberP200015
Product CodeNPV
Device ClassClass f
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Pulmonary valve prosthesis percutaneously delivered is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA Premarket Approval (PMA) on 2020-12-18 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 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 Pulmonary valve prosthesis percutaneously delivered?

Pulmonary valve prosthesis percutaneously delivered is a medical device that received FDA Premarket Approval (PMA) on 2020-12-18. It is manufactured by 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 2020-12-18, under approval number P200015.

What company makes Pulmonary valve prosthesis percutaneously delivered?

Pulmonary valve prosthesis percutaneously delivered is manufactured by Edwards Lifesciences, LLC.

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 Pulmonary valve prosthesis percutaneously delivered?

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

Related Clinical Trials

NCT05883943 Cook Venous Valve System for Treatment of Chronic Venous Insufficiency ACTIVE_NOT_RECRUITING NCT06689553 Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure TERMINATED NCT07564050 Physiological Effects of Different Preoxygenation Strategies RECRUITING NCT07442903 TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure RECRUITING NCT07558265 WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department NOT_YET_RECRUITING NCT07574099 Loading Protocols for Dental Implants Placed in Healed Fully Edentulous Maxilla ACTIVE_NOT_RECRUITING

Other Devices by Edwards Lifesciences, LLC

K161962VAMP Venous/Arterial Blood Management Protection System K160645PreSep Oligon Oximetry Catheter K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform K160084Swan Ganz Catheters K152980Flo Trac sensor, Volume View sensor K172660Duravess bovine pericardial vascular patch

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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.

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