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: LifeStream Balloon Expandable Vascular Covered Stent
• Generic Name: Iliac covered stent, arterial
• Applicant: Bard Peripheral Vascular, Inc.; 1625 W. 3rd St.; Tempe, AZ 85281
• PMA Number: P160024
• Supplement Number: S003
• Date Received: 03/16/2018
• Decision Date: 10/11/2018
• Product Code: PRL
• Advisory Committee: Cardiovascular
• Supplement Type: 135 Review Track For 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  
Adding a sterilization line at the Bard Regional Sterilization, Madison Facility.