PMA P120002S022

Device
Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System
Applicant
Cordis US Corporation
PMA number
P120002
Supplement
S022
Product code
NIP
Decision date
2022-12-07
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
New polyimide supplier.

Current openFDA PMA Record#

Device
Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System
Applicant
Cordis US Corporation
PMA number
P120002
Supplement
S022
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
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.