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Hancock Lowporosity Valved Conduit

by Medtronic, Inc.

PMA P870078

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P870078↗

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 NumberP870078 Date28 Sep 1989ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2623-2014 FDA Class II initiated 15 Aug 2014

    Medtronic has decided to discontinue production and distribution of this low-volume product.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Trade Name
Hancock Porcine Bioprosthesis
Generic Name
replacement Heart-valve
PMA Number
FDA Product Code
DYE
Device Class
Class III
Regulation
21 CFR Part 870.3925
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 Hancock Lowporosity Valved Conduit is a replacement heart-valve device designed for cardiovascular applications. It is manufactured by Medtronic, Inc. and identified by the trade name Hancock Porcine Bioprosthesis.

This device is supplied as a valved conduit and has received FDA Premarket Approval (PMA) under number P870078. It is classified as a Class III medical device and is intended for use in cardiovascular procedures as indicated by its regulatory classification and advisory committee assignment.

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 type of device is the Hancock Lowporosity Valved Conduit?

    The Hancock Lowporosity Valved Conduit is a replacement heart-valve device, as defined by its generic name and FDA classification under regulation number 870.3925 for cardiovascular use.

  • Who manufactures the Hancock Lowporosity Valved Conduit and where are they located?

    The device is manufactured by Medtronic, Inc., located at 1851 E. Deere Ave., Santa Ana, CA 92705, as specified in the device data.

  • What regulatory authorization does the Hancock Lowporosity Valved Conduit have?

    The device has FDA Premarket Approval (PMA) authorization, with PMA number P870078, and was approved on September 28, 1989, following receipt of the application on December 8, 1987.