PMA P120002S036

Device: S.M.A.R.T. and S.M.A.R.T. ® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System
Applicant: Cordis US Corporation
PMA number: P120002
Supplement: S036
Product code: NIP
Decision date: 2026-10-15
Classification: Cardiovascular
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: approval for an alternate supplier of a Bismuth Sub Carbonate Blend used in the catheter outer member

Current openFDA PMA Record#

Device: S.M.A.R.T. and S.M.A.R.T. ® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System
Applicant: Cordis US Corporation
PMA number: P120002
Supplement: S036
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2026-10-15
Decision code: OK30
Date received: 2026-09-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an alternate supplier of a Bismuth Sub Carbonate Blend used in the catheter outer member