PMA P050017S009
- Device
- ZILVER FLEX 35 VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S009
- Product code
- NIO
- Decision date
- 2015-01-07
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.
Current openFDA PMA Record#
- Device
- ZILVER FLEX 35 VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S009
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2015-01-07
- Decision code
- APPR
- Date received
- 2014-04-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.