PMA P050017S004

Device: ZILVER VASCULAR STENT
Applicant: Cook Ireland, Ltd.
PMA number: P050017
Supplement: S004
Product code: NIO
Decision date: 2009-07-23
Classification: Stent, Iliac
Generic name: STENT, ILIAC
Approval order statement: APPROVAL FOR A MODIFICATION FROM THE EXISTING OVER-THE-WIRE DELIVERY SYSTEM TO A RAPID EXCHANGE DELIVERY SYSTEM FOR THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM. PATIENTS MUST BE SUITABLE FOR PTA AND STENT TREATMENT.

Current openFDA PMA Record#

Device: ZILVER VASCULAR STENT
Applicant: Cook Ireland, Ltd.
PMA number: P050017
Supplement: S004
Product code: NIO
Generic name: STENT, ILIAC
Decision date: 2009-07-23
Decision code: APPR
Date received: 2008-08-20
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MODIFICATION FROM THE EXISTING OVER-THE-WIRE DELIVERY SYSTEM TO A RAPID EXCHANGE DELIVERY SYSTEM FOR THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM. PATIENTS MUST BE SUITABLE FOR PTA AND STENT TREATMENT.