ZILVER VASCULAR STENT
FDA premarket approval P050017/S010 · decided 2014-08-14
Approval details
- PMA number
- P050017
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZILVER VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2014-07-15
- Decision date
- 2014-08-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- ADD A MANUFACTURING STEP TO THE HANDLE ASSEMBLY OF THE DELIVERY SYSTEM.
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