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

Ramus Medical Asks FDA To Expand Vascular Graft Prosthesis Definition

This article was originally published in The Gray Sheet

Executive Summary

FDA's definition of a vascular graft prosthesis less than 6 mm in diameter should be expanded to include materials other than those currently referenced and technology used to make the prostheses, Ramus Medical Technologies maintains.

You may also be interested in...



Downclassification Of Six Cardiovascular Devices To Class II Delayed

FDA is postponing the downclassification from Class III to Class II of six cardiovascular devices pending receipt of public comments on guidance documents intended to serve as special controls for the devices.

Ramus Seeking Quick Acceptance Of Rapidgraft In Coronary Bypass Market

Ramus Medical Technologies, a start-up based in Santa Barbara, California, will conduct a 10-patient study of its Rapidgraft Arterial Vessel Substitute as a replacement for a patient's radial artery in the arm when that artery has been removed for use as a coronary artery bypass graft. The purpose is to generate data to support Rapidgraft's use as a replacement vessel in CABG procedures.

PMDA Eyes More Japan-First Approvals In Access Push

Highlighting progress it has made over the past few years, Japan’s regulatory agency says it wants to raise even further the number of “Japan-first” approvals, as part of its stated mission to get safe and effective new drugs to patients more quickly.

UsernamePublicRestriction

Register

OM004967

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