Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ZILVER VASCULAR STENT |
Generic Name | STENT, ILIAC |
Applicant | Cook Ireland, Ltd. O'Halloran Road National Technology Park Limerick |
PMA Number | P050017 |
Supplement Number | S004 |
Date Received | 08/20/2008 |
Decision Date | 07/23/2009 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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. |
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