| 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 | GORE VIATORR TIPS |
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| Classification Name | shunt, portosystemic, endoprosthesis |
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| Generic Name | shunt, postosystemic, endoprosthesis |
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| Applicant | W. L. GORE & ASSOCIATES, INC. |
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| PMA Number | P040027 |
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| Date Received | 06/09/2004 |
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| Decision Date | 12/06/2004 |
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| Product Code | |
| Docket Number | 06M-0411 |
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| Notice Date | 10/17/2006 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | Yes |
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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 gore viatorr tips endoprosthesis. The device is indicated for use in de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropathy, ascites, and/or hepatic hydrothorax. |
| 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 S024 S025
S026 S028 S030 |
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