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: EverFlex Self-Expanding Peripheral Stent System
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Applicant: Medtronic Vascular, Inc.; 3033 Campus Dr.; Plymouth, MN 55441
• PMA Number: P110023
• Supplement Number: S030
• Date Received: 07/21/2020
• Decision Date: 08/18/2020
• Product Code: NIP
• 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 an equivalent CNC machine at a supplier for a catheter component.