Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: BARD E-LUMINEXXVASCULAR STENT
• Generic Name: STENT, ILIAC
• Applicant: Bard Peripheral Vascular, Inc.; 1415 W. 3rd St.; Tempe, AZ 85281
• PMA Number: P080007
• Supplement Number: S014
• Date Received: 05/21/2012
• Decision Date: 06/18/2012
• Product Code: NIO
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
ADDITION OF A QUALITY CONTROL MEASURING MICROSCOPE FOR COMPONENT INSPECTION.