WALLSTENT (TIPS,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA premarket approval P980033/S005 · decided 2003-01-17
Approval details
- PMA number
- P980033
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WALLSTENT (TIPS,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2002-12-18
- Decision date
- 2003-01-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- CHANGE IN THE MANUFACTURING PROCESS OF THE WALLSTENT DELIVERY SYSTEM WHICH INVOLVES THE REPLACEMENT OF THE CATHETER HUB BOND TO STAINLESS STEEL TUBE BOND CURE TIME WITH A REDUCED SET TIME.
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