WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA premarket approval P980033/S006 · decided 2003-04-01
Approval details
- PMA number
- P980033
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2003-03-12
- Decision date
- 2003-04-01
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) MANUAL, NAMELY A MODIFICATION TO THE SIZING REQUIREMENTS OF THE INTRODUCER SHEATHS AND A MODIFICATION TO THE DESCRIPTION OF THE RECOMMENDED GUIDE WIRE TO BE USED WITH THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM.
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