Medtronic, Inc. today announced that it has received CE Mark (Conformité Européene) approval for its next-generation self-expanding carotid stent and filter system, providing patients afflicted by carotid artery disease with a new, minimally-invasive treatment option to surgical procedures for the prevention of stroke.
Medtronic
Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
FDA Seeks Input on Risk-Benefit Reviews for Weight Loss Devices
The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.”
Costa Rican OTC Drugmaker Hit for Testing, Stability Program
The company said it would employ a third-party testing laboratory, but it didn’t provide a description of the test it would conduct.
FDAnews Device Daily Bulletin
MEDTRONIC RECEIVES CE MARK FOR NEW CAROTID STENT AND FILTER
May 1, 2006
