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Monostrut Cardiac Valve Prosthesis

by Alliance Medical Technologies, Inc.

PMA P970002

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 P970002↗

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 NumberP970002 Date30 Sep 1997ApprovedStatusActive

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  • Withdrawn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

Generic Name
HEART-VALVE, MECHANICAL
PMA Number
FDA Product Code
LWQ
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 Monostrut Cardiac Valve Prosthesis is a mechanical heart-valve device designed for the replacement of malfunctioning native or prosthetic mitral and aortic valves. It is classified as a heart-valve, mechanical under the generic nomenclature and falls under the cardiovascular advisory committee category. Available in multiple sizes, it is intended for surgical implantation to restore proper blood flow through the heart.

This device is supplied sterile and intended for single-use in surgical settings. It is approved for use in mitral valve sizes of 27, 29, 31, and 33 mm, and aortic valve sizes of 21, 23, 25, 27, 29, 31, and 33 mm. The Monostrut Cardiac Valve Prosthesis holds an FDA_PMA authorization under PMA number P970002 and is categorized under product code LWQ. No specific MRI safety information is provided in the available data.

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 valve positions is the Monostrut Cardiac Valve Prosthesis approved for replacement, and what sizes are available for each position?

    The Monostrut Cardiac Valve Prosthesis is FDA-authorized for surgical replacement of malfunctioning native or prosthetic **mitral** and **aortic** valves. For mitral valve replacement, sizes 27 mm, 29 mm, 31 mm, and 33 mm are available. For aortic valve replacement, sizes 21 mm, 23 mm, 25 mm, 27 mm, 29 mm, 31 mm, and 33 mm are offered. The device is designed to restore proper blood flow through the heart in these specific positions.

  • Is the Monostrut Cardiac Valve Prosthesis intended for reuse, or is it meant to be used only once during surgery?

    The Monostrut Cardiac Valve Prosthesis is supplied **sterile** and explicitly intended for **single-use** in surgical settings. This means it should not be reused after implantation, as reuse could compromise sterility and patient safety.

  • How is the Monostrut Cardiac Valve Prosthesis supplied, and what should I consider when storing it before use?

    The device is supplied **sterile** and packaged for surgical use. Since it is single-use, it should be stored in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Always follow the manufacturer’s instructions for storage to maintain sterility until the time of use.

  • What regulatory pathway was followed for the approval of the Monostrut Cardiac Valve Prosthesis, and what is its FDA authorization number?

    The Monostrut Cardiac Valve Prosthesis received **FDA Premarket Approval (PMA)** under the PMA number **P970002**. This approval was granted following a review by the **FDA’s Cardiovascular Advisory Committee** and is categorized under product code **LWQ**. The device was filed in 1997 and approved in September 1997.