Medtech Insight is part of the Business Intelligence Division 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


Sen. Grassley Seeks More Documents From Northwestern On Edwards’ Valve Inquiry

This article was originally published in The Gray Sheet

Executive Summary

The Iowa Republican says Northwestern Memorial Hospital may have held back materials in response to his 2008-launched inquiry into use of an Edwards Lifesciences heart valve repair device without FDA clearance or proper patient consent.


Related Content

FDA Listens To Industry Feedback On 510(k) Modifications Guidance Revisions
Grassley Wants More Active FDA Oversight Of 510(k) Modification Decisions
Edwards’ Mitral Valve Repair Device Withdrawn, Under Scrutiny


Related Companies




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