PMA P020036S016

Device
SAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S016
Product code
NIO
Decision date
2011-02-14
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
APPROVAL FOR A CHANGE IN COLORANT USED IN THE CATHETERS OF THE PRECISE AND SMART NITINOL STENT SYSTEMS.

Current openFDA PMA Record#

Device
SAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S016
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2011-02-14
Decision code
APPR
Date received
2010-03-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A CHANGE IN COLORANT USED IN THE CATHETERS OF THE PRECISE AND SMART NITINOL STENT SYSTEMS.