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PASCAL Precision Transcatheter Valve Repair System

FDA PMA

Class III (US FDA PMA)

PMA P220003

by Edwards Lifesciences LLC

Identity

Trade Name
PASCAL Precision Transcatheter Valve Repair System FDA PMA
Generic Name
Mitral valve repair devices FDA PMA

Identifiers

PMA Number
P220003 FDA PMA
FDA Product Code
NKM FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The PASCAL Precision Transcatheter Valve Repair System is a mitral valve repair device designed for percutaneous reduction of significant, symptomatic mitral regurgitation (MR ≥ 3+) due to degenerative mitral apparatus abnormalities. It is intended for patients deemed at prohibitive surgical risk by a heart team, including a cardiac surgeon and a cardiologist specializing in mitral valve disease.

This system is supplied as a sterile, single-use device and is regulated under FDA PMA approval (P220003). It is delivered via a transcatheter approach and is intended for use in clinical settings where advanced cardiovascular interventions are performed. The device’s design adheres to Class III regulatory standards, ensuring compliance with stringent safety and performance requirements for transcatheter heart valves.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pascal (Einheit) – Wikipedia, Pascal (unit) - Wikipedia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Edwards Lifesciences LLC
FDA Applicant
Edwards Lifesciences, LLC

Sources (1)

  • FDA PMA P220003 24 fields · synced Sep 18, 2026