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: MISAGO RX Self-expanding Peripheral Stent System
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Applicant: Terumo Medical Corporation; 950 Elkton Blvd.; Hatagaya 151-0072
• PMA Number: P140002
• Supplement Number: S021
• Date Received: 05/10/2021
• Decision Date: 06/09/2021
• 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  
Replace UV irradiation equipment.