PMA P140002S004

Device
MISAGO RX SELF-EXPANDING PERIPHERAL STENT
Applicant
Terumo Medical Corporation
PMA number
P140002
Supplement
S004
Product code
NIP
Decision date
2016-10-18
Classification
Stent, Superficial Femoral Artery
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
Modified processing time for a manufacturing step.

Current openFDA PMA Record#

Device
MISAGO RX SELF-EXPANDING PERIPHERAL STENT
Applicant
Terumo Medical Corporation
PMA number
P140002
Supplement
S004
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 processing time for a manufacturing step.