PMA P050017S006

Device: ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
Applicant: Cook Ireland, Ltd.
PMA number: P050017
Supplement: S006
Product code: NIO
Decision date: 2011-07-05
Classification: Stent, Iliac
Generic name: STENT, ILIAC
Approval order statement: APPROVAL FOR A PRODUCT LINE EXTENSION THAT REPRESENTS MODIFICATIONS TO THE 6FR VERSION OF THE ZILVER VASCULAR STENT. IN ADDITION, APPROVAL OF MINOR CHANGES TO THE STENT AND DELIVERY SYSTEM AND THE ADDITION OF A 100 MM LENGTH STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZILVER FLEX 35 VASCULAR STENT 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 AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
Applicant: Cook Ireland, Ltd.
PMA number: P050017
Supplement: S006
Product code: NIO
Generic name: STENT, ILIAC
Decision date: 2011-07-05
Decision code: APPR
Date received: 2011-04-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A PRODUCT LINE EXTENSION THAT REPRESENTS MODIFICATIONS TO THE 6FR VERSION OF THE ZILVER VASCULAR STENT. IN ADDITION, APPROVAL OF MINOR CHANGES TO THE STENT AND DELIVERY SYSTEM AND THE ADDITION OF A 100 MM LENGTH STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZILVER FLEX 35 VASCULAR STENT 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.