PMA P890017

Device: Cordis® PALMAZ® Balloon-Expandable Stent
Applicant: Cordis US Corporation
PMA number: P890017
Supplement: S023
Product code: NIO
Decision date: 2022-12-20
Generic name: STENT, ILIAC
Approval order statement: Approval to remove references to obsoleted accessory devices and add instructions for unaided manual crimping of the stent implant to a stent delivery system (i.e., balloon catheter) in the Instructions For Use (IFU) document.

Current openFDA PMA Record#

Device: Cordis® PALMAZ® Balloon-Expandable Stent
Applicant: Cordis US Corporation
PMA number: P890017
Supplement: S023
Product code: NIO
Generic name: STENT, ILIAC
Decision date: 2022-12-20
Decision code: APPR
Date received: 2022-09-28
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to remove references to obsoleted accessory devices and add instructions for unaided manual crimping of the stent implant to a stent delivery system (i.e., balloon catheter) in the Instructions For Use (IFU) document.