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Avalus Bioprosthesis Model 400

by Medtronic, Inc.

PMA P170006

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P170006↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP170006 Date31 Jul 2017ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Avalus
Trade name
Avalus(Tm) Bioprosthesis
Generic name
heart-valve, non-allograft tissue
PMA number
FDA product code
LWR
Device class
Class III
Advisory committee
Cardiovascular
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Avalus Bioprosthesis, Model 400, is a non-allograft tissue heart valve designed for surgical implantation. It is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

This device is manufactured by Medtronic, Inc. and has received FDA PMA approval. It is intended for use in cardiovascular procedures to restore proper valve function in patients requiring aortic valve replacement.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Avalus Bioprosthesis used for?

    The Avalus Bioprosthesis is indicated for the replacement of native or prosthetic aortic valves that are diseased, damaged, or malfunctioning.

  • Who manufactures the Avalus Bioprosthesis?

    The Avalus Bioprosthesis is manufactured by Medtronic, Inc., based in Santa Ana, California.

  • Has the Avalus Bioprosthesis received regulatory approval?

    Yes, the Avalus Bioprosthesis, Model 400, has received FDA PMA approval under the docket number 17M-4756.