PMA P140002S011
- Device
- Misago RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S011
- Product code
- NIP
- Decision date
- 2018-08-01
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for a change to the supplier of the device pouch.
Current openFDA PMA Record#
- Device
- Misago RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S011
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2018-08-01
- Decision code
- APPR
- Date received
- 2018-04-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the supplier of the device pouch.