MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
FDA premarket approval P140002 · decided 2015-05-22
Approval details
- PMA number
- P140002
- Trade name
- MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Terumo Medical Corporation
- Date received
- 2014-03-06
- Decision date
- 2015-05-22
- Days to decision
- 442 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hatagaya
- 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.
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