ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
FDA premarket approval P050017/S006 · decided 2011-07-05
Approval details
- PMA number
- P050017
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2011-04-04
- Decision date
- 2011-07-05
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- 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 LE
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