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: E-LUMINEXX VASCULAR STENT
• Classification Name: stent, iliac
• Generic Name: iliac stent
• Applicant: BARD PERIPHERAL VASCULAR, INC.
• PMA Number: P080007
• Supplement Number: S009
• Date Received: 10/28/2011
• Decision Date: 11/17/2011
• Product Code: NIO [ Registered Establishments with NIO ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of a new system to monitor environmental controls.