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

Artificial embolization devices

This article was originally published in The Gray Sheet

Executive Summary

Preamendment Class III artificial embolization devices for neurological use are unanimously (7-0) recommended for downclassification to Class II at a June 12 Neurological Devices Panel meeting. The devices obstruct blood flow to an aneurysm or other vascular malformation. The recommendation is based on data submitted to the agency by three manufacturers following an FDA call for data under Sec. 515(i) of device law and presented to the panel by FDA. Panel members note that the products have been used safely and effectively for more than 20 years. Suggesting that additional labeling should be required that emphasizes that only specially trained surgeons use the product, the panel agrees that special controls would be sufficient to ensure safety
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT010181

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

Cancel