ZILVER VASCULAR STENT
FDA premarket approval P050017/S004 · decided 2009-07-23
Approval details
- PMA number
- P050017
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZILVER VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2008-08-20
- Decision date
- 2009-07-23
- Days to decision
- 337 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- 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 SUITAB
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