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: WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER
• Classification Name: intracranial neurovascular stent
• Generic Name: intracranial neurovascular stent
• Applicant: STRYKER CORP.; 47900 bayside parkway; fremont, CA 94538
• HDE Number: H050001
• Supplement Number: S035
• Date Received: 05/13/2011
• Decision Date: 07/11/2011
• Product Code: NJE [ Registered Establishments with NJE ]
• Advisory Committee: Neurology
• Supplement Type: 30-day notice
• Supplement Reason: labeling change - indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No