ZILVER VASCULAR STENT
FDA premarket approval P050017 · decided 2006-06-26
Approval details
- PMA number
- P050017
- Trade name
- ZILVER VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2005-04-15
- Decision date
- 2006-06-26
- Days to decision
- 437 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- APPROVAL FOR THE ZILVER VASCULAR STENT. THIS DEVICE 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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