PMA P140002S029

Device: MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System
Applicant: Terumo Medical Corporation
PMA number: P140002
Supplement: S029
Product code: NIP
Decision date: 2025-08-05
Classification: Cardiovascular
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: to replace the current ethylene oxide sterilizer with three other EO sterilizers at the same sterilization site

Current openFDA PMA Record#

Device: MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System
Applicant: Terumo Medical Corporation
PMA number: P140002
Supplement: S029
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2025-08-05
Decision code: OK30
Date received: 2025-07-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to replace the current ethylene oxide sterilizer with three other EO sterilizers at the same sterilization site