Zilver® Vascular Stent
FDA premarket approval P050017/S020 · decided 2023-02-22
Approval details
- PMA number
- P050017
- Supplement
- S020
- 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
- 2023-01-30
- Decision date
- 2023-02-22
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Alternate supplier for a component of external process challenge device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.