WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA premarket approval P980033/S010 · decided 2004-05-07
Approval details
- PMA number
- P980033
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2004-04-09
- Decision date
- 2004-05-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- CHANGE IN THE MANUFACTURING MATERIAL USED IN THE MANUFACTURE OF THE EXTERIOR TUBE FOR THE DEVICE.
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