PMA P050017S011
- Device
- ZILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S011
- Product code
- NIO
- Decision date
- 2015-08-13
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR THE ADDITION OF A TACTILE INSPECTION STEP DURING INCOMING QUALITY CONTROL.
Current openFDA PMA Record#
- Device
- ZILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S011
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2015-08-13
- Decision code
- APPR
- Date received
- 2015-07-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A TACTILE INSPECTION STEP DURING INCOMING QUALITY CONTROL.