PMA P140002S030
- Device
- MISAGO® RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S030
- Product code
- NIP
- Decision date
- 2025-09-12
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- changes to the endotoxin test procedures and the addition of a lubricant to non-patient-contacting components
Current openFDA PMA Record#
- Device
- MISAGO® RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S030
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2025-09-12
- Decision code
- OK30
- Date received
- 2025-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the endotoxin test procedures and the addition of a lubricant to non-patient-contacting components