Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Applicant: Terumo Medical Corporation; 950 Elkton Blvd.; Hatagaya 151-0072
• PMA Number: P140002
• Date Received: 03/06/2014
• Decision Date: 05/22/2015
• Product Code: NIP
• Docket Number: 15M-1958
• Notice Date: 06/05/2015
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT01118117
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN SYMPTOMATIC PATIENTS WITH DE NOVO OR RESTENOTIC NATIVE LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4MM TO 7MM AND LESION LENGTH UP TO 150MM.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 ; S013 S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 ; S026 S027 S028 S029 S030 S031 S032 S033