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Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Inspiris Resilia Aortic Valve

FDA PMA

Class III (US FDA PMA)

PMA P150048

by Edwards Lifesciences LLC

Identity

Trade Name
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) FDA PMA
Generic Name
heart-valve, non-allograft tissue FDA PMA

Identifiers

PMA Number
P150048 FDA PMA
FDA Product Code
LWR FDA PMA

Classification

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

The Edwards Pericardial Aortic Bioprosthesis and Edwards Inspiris Resilia Aortic Valve are heart valves used for the replacement of native or prosthetic aortic heart valves. The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, and the Edwards Inspiris Resilia Aortic Valve, Model 11500A, are indicated for this purpose. These devices are classified as non-allograft tissue heart valves.

The devices are supplied by Edwards Lifesciences LLC, and have been authorized by the FDA. The Edwards Pericardial Aortic Bioprosthesis and Edwards Inspiris Resilia Aortic Valve are part of the company's structural heart innovation portfolio. The devices are designed to help patients with advanced heart and vascular diseases.

Frequently asked questions

What is the Edwards Pericardial Aortic Bioprosthesis used for?

The Edwards Pericardial Aortic Bioprosthesis is used for the replacement of native or prosthetic aortic heart valves.

What models are available for the Edwards Pericardial Aortic Bioprosthesis and Edwards Inspiris Resilia Aortic Valve?

The available models are the Edwards Pericardial Aortic Bioprosthesis, Model 11000A, and the Edwards Inspiris Resilia Aortic Valve, Model 11500A.

Who is the manufacturer of the Edwards Pericardial Aortic Bioprosthesis and Edwards Inspiris Resilia Aortic Valve?

The manufacturer of the Edwards Pericardial Aortic Bioprosthesis and Edwards Inspiris Resilia Aortic Valve is Edwards Lifesciences LLC.

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: Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences – Wikipedia, Edwards Lifesciences - Wikipedia, Edwards Lifesciences - Herzmedizin.de

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 P150048 24 fields · synced Sep 18, 2026