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: SMART CONTROL NITINOL STENT SYSTEM
• Classification Name: stent, iliac
• Generic Name: iliac stent
• Applicant: CORDIS CORP.
• PMA Number: P020036
• Supplement Number: S001
• Date Received: 10/29/2003
• Decision Date: 05/12/2006
• Product Code: NIO [ Registered Establishments with NIO ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: location change: manufacturer
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a manufacturing site located at cordis de mexico, chihuahua, mexico.