PMA P140002S022
- Device
- MISAGO® RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S022
- Product code
- NIP
- Decision date
- 2022-10-21
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Modification of the sterilization cycle and validation method.
Current openFDA PMA Record#
- Device
- MISAGO® RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S022
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2022-10-21
- Decision code
- OK30
- Date received
- 2022-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of the sterilization cycle and validation method.