PMA P140002S017

Device
MISAGO RX Self-expanding Peripheral Stent
Applicant
Terumo Medical Corporation
PMA number
P140002
Supplement
S017
Product code
NIP
Decision date
2018-09-20
Classification
Stent, Superficial Femoral Artery
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
Installation of a gas chromatography data system.

Current openFDA PMA Record#

Device
MISAGO RX Self-expanding Peripheral Stent
Applicant
Terumo Medical Corporation
PMA number
P140002
Supplement
S017
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2018-09-20
Decision code
OK30
Date received
2018-08-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Installation of a gas chromatography data system.