Premarket Approval (PMA)

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

• Trade Name: ZILVER VASCULAR STENT
• Classification Name: stent, iliac
• Applicant: COOK INCORPORATED
• PMA Number: P050017
• Supplement Number: S001
• Date Received: 10/12/2007
• Decision Date: 11/09/2007
• Product Code: NIO [ Registered Establishments with NIO ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change in sterilant.