PMA P020036S042

Device: Cordis S.M.A.R.T. CONTROL Nitinol Stent System
Applicant: Cordis US Corporation
PMA number: P020036
Supplement: S042
Product code: NIO
Decision date: 2020-05-29
Generic name: STENT, ILIAC
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 Nitinol Stent System
Applicant: Cordis US Corporation
PMA number: P020036
Supplement: S042
Product code: NIO
Generic name: STENT, ILIAC
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.