WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA premarket approval P980033/S017 · decided 2011-01-07
Approval details
- PMA number
- P980033
- Supplement
- S017
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2010-04-08
- Decision date
- 2011-01-07
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
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