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: VenaSeal Closure System
• Generic Name: Agent, occluding, vascular, permanent
• Applicant: Medtronic Vascular, Inc.; 3033 Campus Dr.; Plymouth, MN 55441
• PMA Number: P140018
• Supplement Number: S009
• Date Received: 02/26/2018
• Decision Date: 03/27/2018
• Product Code: PJQ
• 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  
Implementation of a modified sample preparation method for bacterial endotoxin testing of the VenaSeal Closure System.