WALLSTENT ENDOPROSTHESIS
FDA premarket approval P980033 · decided 2001-11-16
Approval details
- PMA number
- P980033
- Trade name
- WALLSTENT ENDOPROSTHESIS
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 1998-08-03
- Decision date
- 2001-11-16
- Days to decision
- 1201 days
- Decision code
- APPR
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS RP DELIVERY SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS (12 MM - 16 MM VENOUS ENDOPROSTHESES). THESE DEVICES ARE INDICATED FOR IMPROVING CENTRAL VENOUS LUMINAL DIAMETER FOLLOWING UNSECCESSFUL ANGIOPLASTY IN PATIENTS ON CHRONIC HEMODIALYSIS WITH STENOSIS OF THE VENOUS OUTFLOW TRACT. UNSUCCESSFUL ANGIOPLASTY IS DEFINED AS RESIDUAL STENOSIS >= 30 PERCENT FOR A VEIN
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