PMA P140002S009

Device
Misago RX Self-expanding Peripheral Stent
Applicant
Terumo Medical Corporation
PMA number
P140002
Supplement
S009
Product code
NIP
Decision date
2018-02-15
Classification
Stent, Superficial Femoral Artery
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
Approval for the addition of new analytical equipment used for residual testing of the MISAGO RX Self-Expanding Peripheral Stent.
Summary
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Current openFDA PMA Record#

Device
Misago RX Self-expanding Peripheral Stent
Applicant
Terumo Medical Corporation
PMA number
P140002
Supplement
S009
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2018-02-15
Decision code
APPR
Date received
2017-09-14
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the addition of new analytical equipment used for residual testing of the MISAGO RX Self-Expanding Peripheral Stent.