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: Venovo Venous Stent System
• Generic Name: Stent, iliac vein
• Applicant: Bard Peripheral Vascular, Inc.; 1625 W Third St.; Tempe, AZ 85281
• PMA Number: P180037
• Supplement Number: S011
• Date Received: 05/19/2022
• Decision Date: 05/23/2022
• Product Code: QAN
• 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  
Delivery system manufacturing process and inspection changes for the 8 French size.