Zilver Vena Venous Self-Expanding Stent
FDA premarket approval P200023/S007 · decided 2024-02-08
Approval details
- PMA number
- P200023
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zilver Vena Venous Self-Expanding Stent
- Generic name
- Stent, iliac vein
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2023-10-27
- Decision date
- 2024-02-08
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- changes to the materials used in your delivery system sheath assembly
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