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: S011
• Date Received: 09/30/2021
• Decision Date: 02/11/2022
• Product Code: PRL
• Advisory Committee: Cardiovascular
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for modifying the materials of the packaging sterile barrier.