- Device
- WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S017
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2011-01-07
- Decision code
- APPR
- Date received
- 2010-04-08
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.