|
Device | MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | TERUMO MEDICAL CORPORATION 950 ELKTON BLVD ELKTON, MD 21921 |
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 |
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 |