PMA P050017S026

Device: Zilver® Flex® 35 Vascular Stent; Zilver® 635® Vascular Stent; Zilver® 518® Vascular Stent
Applicant: Cook Ireland, Ltd.
PMA number: P050017
Supplement: S026
Product code: NIO
Decision date: 2026-04-14
Classification: Cardiovascular
Generic name: STENT, ILIAC
Approval order statement: add Cook Polymer Technology as an additional supplier of the polytetrafluoroethylene tubing used in the delivery system component

Current openFDA PMA Record#

Device: Zilver® Flex® 35 Vascular Stent; Zilver® 635® Vascular Stent; Zilver® 518® Vascular Stent
Applicant: Cook Ireland, Ltd.
PMA number: P050017
Supplement: S026
Product code: NIO
Generic name: STENT, ILIAC
Decision date: 2026-04-14
Decision code: OK30
Date received: 2026-03-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: add Cook Polymer Technology as an additional supplier of the polytetrafluoroethylene tubing used in the delivery system component