Zilver Vascular Stent
FDA premarket approval P050017/S018 · decided 2020-02-07
Approval details
- PMA number
- P050017
- Supplement
- S018
- 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
- 2020-01-08
- Decision date
- 2020-02-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Change to the delivery system tip manufacturing process.
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