PMA P140002

Device: MISAGO(TM) RX Self-expanding Peripheral Stent
Applicant: Terumo Medical Corporation
PMA number: P140002
Supplement: S023
Product code: NIO
Decision date: 2026-07-16
Generic name: STENT, ILIAC
Approval order statement: The Misago RX Self-expanding Peripheral Stent is indicated to improve the luminal diameter in patient with de novo, restenotic and/or occlusive atherosclerotic lesion(s) in the common and/or external iliac artery. The reference vessel diameters range from 4.0 mm to 9.0 mm and the lesion length is up to 120 mm.

Current openFDA PMA Record#

Device: MISAGO(TM) RX Self-expanding Peripheral Stent
Applicant: Terumo Medical Corporation
PMA number: P140002
Supplement: S032
Product code: NIO
Generic name: STENT, ILIAC
Decision date: 2026-07-16
Decision code: APPR
Date received: 2025-12-29
Supplement type: Panel Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: The Misago RX Self-expanding Peripheral Stent is indicated to improve the luminal diameter in patient with de novo, restenotic and/or occlusive atherosclerotic lesion(s) in the common and/or external iliac artery. The reference vessel diameters range from 4.0 mm to 9.0 mm and the lesion length is up to 120 mm.