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


FDA Panel Recommends Split Classifications For Cardiac Devices

This article was originally published in The Gray Sheet

Executive Summary

Circulatory System Devices panel recommends either class II or class III designations for external counter-pulsating devices and intra-aortic balloon pumps, depending on the indication.

You may also be interested in...

Class Act: Status Of CDRH’s 515 Initiative

Chart updating FDA’s progress and decisions in classifying the final set of preamendment devices.

Regulatory News In Brief

Agency issues proposed orders to reclassify intra-aortic balloon and control systems, tuberculosis IVDs and stair-climbing wheelchairs. Industry mainly supports FDA’s communications draft guidance. More regulatory news.

Abiomed’s Impella Cardiac Pump Needs PMA Study, FDA Panel Says

Better data is needed in the form of a PMA study to assess the safety and effectiveness of Abiomed’s flagship Impella 2.5 blood pump, advisory panel recommends.


Latest Headlines
See All



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