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
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Applicant: Terumo Medical Corporation; 950 Elkton Blvd.; Hatagaya 151-0072
• PMA Number: P140002
• Supplement Number: S022
• Date Received: 09/21/2022
• Decision Date: 10/21/2022
• 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  
Modification of the sterilization cycle and validation method.