Stent, Central Venous
Basic Information
- Device Name
- Stent, Central Venous
- Trade Name
- WALLSTENT ENDOPROSTHESIS
- PMA Number
- P980033
- Device Class
- FDA Class 3
- Product Code
- QKJ
- Generic Name
- Stent, central venous
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 16, 2001
- Date Received
- August 3, 1998
- Expedited Review
- N
- Docket Number
- 02M-0203
Advisory Committee 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 <= 10 MM IN DIAMETER OR >= 50 PERCENT FOR A VEIN > 10 MM IN DIAMETER, A TEAR WHICH INTERRUPTS THE INTEGRITY OF THE INTIMA OR LUMEN, ABRUPT LESION SITE OCCLUSION, OR REFRACTORY SPASM. THE VESSELS THAT CAN BE TREATED WITH THE DEVICE ARE THE INNOMINATE AND SUBCLAVIAN VEINS RANGING FROM 8 MM TO 15 MM IN DIAMETER.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QKJ | Stent, Central Venous | FDA class 3 | Unknown |