PMA P050017S008
- Device
- ZILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S008
- Product code
- NIO
- Decision date
- 2013-08-22
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- CHANGE THE MANUFACTURING PROCESS OF FLARING THE POLYETHYLENE REINFORCED SLEEVES FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.
Current openFDA PMA Record#
- Device
- ZILVER VASCULAR STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S008
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2013-08-22
- Decision code
- OK30
- Date received
- 2013-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE THE MANUFACTURING PROCESS OF FLARING THE POLYETHYLENE REINFORCED SLEEVES FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.