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


Medtronic Voluntary Response To MIS Data Integrity Problems Averts AIP

This article was originally published in The Gray Sheet

Executive Summary

Medtronic's voluntary actions to ensure data integrity in premarket submissions from its Micro Interventional Systems unit appears to have helped avert imposition of FDA's application integrity policy.

You may also be interested in...

MIS Execs Allegedly Defrauded FDA During Acquisition Talks With Medtronic

While Micro Interventional Systems was in discussions with Medtronic about a possible acquisition in November 1995, two executives at the Sunnyvale, California-based firm allegedly were falsifying data in various 510(k) submissions to FDA in an apparent attempt to impress Medtronic with the breadth of MIS' neurovascular product pipeline.

US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates

Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.




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