PMA P140002S018
- Device
- MISAGO RX self-expanding Peripheral stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S018
- Product code
- NIP
- Decision date
- 2018-11-09
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Minor changes to the packaging process for the sterile barrier system of the MISAGO RX Self-expanding Peripheral Stent ("MISAGO") System.
Current openFDA PMA Record#
- Device
- MISAGO RX self-expanding Peripheral stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S018
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2018-11-09
- Decision code
- OK30
- Date received
- 2018-10-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Minor changes to the packaging process for the sterile barrier system of the MISAGO RX Self-expanding Peripheral Stent ("MISAGO") System.