ZILVER VASCULAR STENT AND SILVER VASCULAR STENT
FDA premarket approval P050017/S005 · decided 2010-04-12
Approval details
- PMA number
- P050017
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ZILVER VASCULAR STENT AND SILVER VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2010-02-19
- Decision date
- 2010-04-12
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- APPROVAL FOR REVISED PRODUCT LABELING.
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