PMA P050017S013
- Device
- ZILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S013
- Product code
- NIO
- Decision date
- 2016-07-01
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Alternate resin for several delivery system components.
Current openFDA PMA Record#
- Device
- ZILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S013
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2016-07-01
- Decision code
- OK30
- Date received
- 2016-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate resin for several delivery system components.