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 AND SILVER VASCULAR STENT
• Classification Name: stent, iliac
• Applicant: COOK INCORPORATED
• PMA Number: P050017
• Supplement Number: S005
• Date Received: 02/19/2010
• Decision Date: 04/12/2010
• Product Code: NIO [ Registered Establishments with NIO ]
• Advisory Committee: Cardiovascular
• Supplement Type: real-time process
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for revised product labeling.