PMA P050017S014
- Device
- ZILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S014
- Product code
- NIO
- Decision date
- 2016-12-16
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Approval for additional quality control inspections.
Current openFDA PMA Record#
- Device
- ZILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S014
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2016-12-16
- Decision code
- APPR
- Date received
- 2016-11-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional quality control inspections.