PMA P020036S047

Device
Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S047
Product code
NIO
Decision date
2022-12-07
Generic name
STENT, ILIAC
Approval order statement
New polyimide supplier.

Current openFDA PMA Record#

Device
Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System
Applicant
Cordis US Corporation
PMA number
P020036
Supplement
S047
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2022-12-07
Decision code
OK30
Date received
2022-11-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New polyimide supplier.