PMA P050017S003

Device: ZILVER VASCULAR STENT
Applicant: Cook Ireland, Ltd.
PMA number: P050017
Supplement: S003
Product code: NIO
Decision date: 2009-02-03
Classification: Stent, Iliac
Generic name: STENT, ILIAC
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK IRELAND, LTD., LIMERICK, IRELAND FOR MANUFACTURING AND FINAL MANUFACTURING TO INCLUDE LABELING AND PACKAGING, AND FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD., TULLAMORE, IRELAND.

Current openFDA PMA Record#

Device: ZILVER VASCULAR STENT
Applicant: Cook Ireland, Ltd.
PMA number: P050017
Supplement: S003
Product code: NIO
Generic name: STENT, ILIAC
Decision date: 2009-02-03
Decision code: APPR
Date received: 2008-07-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK IRELAND, LTD., LIMERICK, IRELAND FOR MANUFACTURING AND FINAL MANUFACTURING TO INCLUDE LABELING AND PACKAGING, AND FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD., TULLAMORE, IRELAND.