| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Duo Venous Stent System |
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| Generic Name | Stent, iliac vein |
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| Applicant | Vesper Medical, Inc.
1285 Drummers Lane
Suite 105
Wayne, PA 19087 |
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| PMA Number | P230021 |
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| Date Received | 07/03/2023 |
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| Decision Date | 12/26/2023 |
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| Product Code |
QAN |
| Docket Number | 24M-0045 |
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| Notice Date | 01/10/2024 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT04580160
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
The Duo Venous Stent System is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The Duo Hybrid is intended to be used in the iliac vein at the confluence of the inferior vena cava only. The Duo Extend is intended for use in the common iliac and common femoral veins. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 |
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|
