PMA P140002S021

Device
MISAGO RX Self-expanding Peripheral Stent System
Applicant
Terumo Medical Corporation
PMA number
P140002
Supplement
S021
Product code
NIP
Decision date
2021-06-09
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
Replace UV irradiation equipment.

Current openFDA PMA Record#

Device
MISAGO RX Self-expanding Peripheral Stent System
Applicant
Terumo Medical Corporation
PMA number
P140002
Supplement
S021
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2021-06-09
Decision code
OK30
Date received
2021-05-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replace UV irradiation equipment.