Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.

• Trade Name: NEUROFORM EZ 2 STENT SYSTEM & NEUROFORM EZ 3 STENT SYSTEM ACCESSORY KIT
• Classification Name: intracranial neurovascular stent
• Generic Name: intracranial neurovascular stent
• Applicant: Stryker Neurovascular; 47900 bayside parkway; fremont, CA 94538
• HDE Number: H020002
• Supplement Number: S027
• Date Received: 03/07/2011
• Decision Date: 04/04/2011
• Product Code: NJE [ Registered Establishments with NJE ]
• Advisory Committee: Neurology
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No