ZILVER VASCULAR STENT
FDA premarket approval P050017/S014 · decided 2016-12-16
Approval details
- PMA number
- P050017
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZILVER VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2016-11-18
- Decision date
- 2016-12-16
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Approval for additional quality control inspections.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.