| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | VASCADE MVP Venous Vascular Closure System (VVCS) |
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| Generic Name | Device, hemostasis, vascular |
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| Applicant | Cardiva Medical, Inc.
2900 Lakeside Dr., Suite 160
Santa Clara, CA 95054 |
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| PMA Number | P120016 |
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| Supplement Number | S024 |
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| Date Received | 05/30/2018 |
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| Decision Date | 11/27/2018 |
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| Product Code |
MGB |
| Docket Number | 18M-4582 |
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| Notice Date | 12/06/2018 |
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| Advisory Committee |
Cardiovascular |
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| Supplement Type | Panel Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6-12F inner diameter procedural sheaths, with single or multiple access sites in one or both limbs. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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