PMA P140002S031
- Device
- MISAGO® RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S031
- Product code
- NIP
- Decision date
- 2025-12-12
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- packaging material, performance testing, and label placement changes
Current openFDA PMA Record#
- Device
- MISAGO® RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S031
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2025-12-12
- Decision code
- APPR
- Date received
- 2025-09-15
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- packaging material, performance testing, and label placement changes