Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Medtronic Transcatheter Pulmonary Valve Study Begins Under Draft FDA Feasibility Study Guidance

This article was originally published in The Gray Sheet

Executive Summary

In granting IDE approval for a feasibility study of Medtronic’s Native Outflow Tract Transcatheter Pulmonary Valve, FDA followed a pathway laid out in a November 2011 draft guidance intended to streamline requirements for starting up and modifying early feasibility studies.

You may also be interested in...



CardiAQ Uses Early-Feasibility IDE Paradigm To Bring Trans-Mitral Valve Device To U.S. Clinicians

The California startup was able to leverage a new FDA process for early-feasibility device trials to launch a small U.S. study of its transfemoral and transapical transcatheter mitral valve implantation systems.

CDRH Sequestration Impact: Training, Standards And Reg Science

CDRH Director Jeffrey Shuren detailed last week how federal sequestration cuts to FDA are impacting specific device center programs, including training, standards development and regulatory science. Shuren also signaled imminent policy releases from the center, including a finalized post-market surveillance plan.

Regulatory News In Brief

FDA issues safety notice on Covidien catheter. Medtronic stent graft selected for FDA’s early feasibility pilot program. More regulatory news.

Related Content

Topics

UsernamePublicRestriction

Register

MT032769

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel