FDA.reportPublic FDA data

PMA P120002S017

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
S017
Product code
NIP
Decision date
2020-05-29
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
Updates to the software and mechanical components of the control system for Vessel 2 and Vessel 4 at the Steris, El Paso, TX ethylene oxide sterilization facility.

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
S017
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2020-05-29
Decision code
OK30
Date received
2020-05-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updates to the software and mechanical components of the control system for Vessel 2 and Vessel 4 at the Steris, El Paso, TX ethylene oxide sterilization facility.