Perimount Pericardial Bioprosthesis Models 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX, 6900P Perimount Plus, 6900PTFX

FDA PMA

Class III (US FDA PMA)

PMA P860057

by Edwards Lifesciences LLC

Identity

Trade Name: EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES FDA PMA
Generic Name: replacement Heart-valve FDA PMA

Identifiers

PMA Number: P860057 FDA PMA
FDA Product Code: DYE FDA PMA
Models / Variants: 2700 FDA PMA
2700tfx FDA PMA
2800 FDA PMA
2800tfx FDA PMA
3000 FDA PMA
3000tfx FDA PMA
6900p Perimount Plus FDA PMA
6900ptfx FDA PMA

Classification

Device Class: Class III FDA PMA
Legislation / Framework: 21 CFR Part 870.3925 FDA PMA
Regulation Number: 870.3925 FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA

The Perimount Pericardial Bioprosthesis is a replacement heart-valve designed for patients with advanced aortic valvular disease. It is indicated for individuals who require the replacement of their natural valve with a prosthetic one or for those needing to replace a previously implanted aortic valve prosthesis that is no longer functioning adequately.

This device is manufactured by Edwards Lifesciences and has received FDA PMA authorization. It is categorized under cardiovascular medical devices and is intended for clinical use in patients meeting the specified criteria for heart valve replacement.

Frequently asked questions

What is the primary purpose of the Perimount Pericardial Bioprosthesis?

The device is a replacement heart-valve intended for patients whose aortic valvular disease is advanced enough to require the replacement of their natural valve with a prosthetic one.

Can this device be used to replace a previously implanted valve?

Yes, the device is indicated for use in patients who have a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement.

Who is the manufacturer of the Perimount Pericardial Bioprosthesis?

The device is manufactured by Edwards Lifesciences, based in Irvine, California.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P860057	Class III	Active

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Manufacturer

Manufacturer: Edwards Lifesciences LLC
FDA Applicant: Edwards Lifesciences, LLC

Sources (1)

FDA PMA P860057 24 fields · synced Sep 18, 2026