PMA P020036S038

Device
S.M.A.R.T. Control Nitinol Stent System
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S038
Product code
NIO
Decision date
2018-03-20
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
Modification to a supplier processing aid.

Current openFDA PMA Record#

Device
S.M.A.R.T. Control Nitinol Stent System
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S038
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2018-03-20
Decision code
OK30
Date received
2018-02-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to a supplier processing aid.