PMA P140002S003
- Device
- MISAGO RX SELF-EXPANDING PERIPHERAL STENT
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S003
- Product code
- NIP
- Decision date
- 2016-10-18
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Modified extrusion process parameters and changes to in-process inspection specifications.
Current openFDA PMA Record#
- Device
- MISAGO RX SELF-EXPANDING PERIPHERAL STENT
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S003
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2016-10-18
- Decision code
- OK30
- Date received
- 2016-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modified extrusion process parameters and changes to in-process inspection specifications.