PMA P050017S005
- Device
- ZILVER VASCULAR STENT AND SILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S005
- Product code
- NIO
- Decision date
- 2010-04-12
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR REVISED PRODUCT LABELING.
Current openFDA PMA Record#
- Device
- ZILVER VASCULAR STENT AND SILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S005
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2010-04-12
- Decision code
- APPR
- Date received
- 2010-02-19
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED PRODUCT LABELING.