Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Endocardial Solutions

This article was originally published in The Gray Sheet

Executive Summary

Submits a 510(k) to FDA for the Ensite 3000 3D mapping system for diagnosing arrhythmias in the right atrium of the heart. Under a 1997 investigation device exemption, data for the application were collected at the Cleveland Clinic, Mayo Clinic, Northwestern University Hospital, Temple University Hospital and the University of Michigan Medical Center

Latest Headlines
See All
UsernamePublicRestriction

Register

MT010702

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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