| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | WALLSTENT ENDOPROSTHESIS |
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| Classification Name | stent, coronary |
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| Generic Name | intravascular stent |
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| Applicant | BOSTON SCIENTIFIC CORPORATION |
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| PMA Number | P980033 |
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| Date Received | 08/03/1998 |
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| Decision Date | 11/16/2001 |
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| Product Code | |
| Docket Number | 02M-0203 |
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| Notice Date | 05/09/2002 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order 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. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 S006
S007 S008 S009 S010 S011 S012
S013 S014 S015 S016 S017 S018
S019 S020 S021 S022 S023 S024
S025 S026 S027 S028 S030 S031
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