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: NEUROFORM2 AND NEUROFORM3 MICRODELIVERY STENT SYSTEMS
• Classification Name: intracranial neurovascular stent
• Generic Name: intracranial neurovascular stent
• Applicant: Stryker Neurovascular; 47900 bayside pkwy.; fremont, CA 94538
• HDE Number: H020002
• Supplement Number: S015
• Date Received: 10/06/2008
• Decision Date: 01/22/2009
• Product Code: NJE [ Registered Establishments with NJE ]
• Advisory Committee: Neurology
• Supplement Type: special (immediate track)
• Supplement Reason: labeling change - indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No