| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | MYNX VASCULAR CLOSURE DEVICE |
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| Classification Name | device, hemostasis, vascular |
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| Applicant | ACCESS CLOSURE, INC. |
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| PMA Number | P040044 |
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| Supplement Number | S001 |
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| Date Received | 04/06/2006 |
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| Decision Date | 05/16/2007 |
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| Product Code | |
| Docket Number | 07M-0285 |
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| Notice Date | 07/20/2007 |
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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 - specifications |
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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 mynx vascular closure system. The device is indicted for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5f, 6f, or 7f procedural sheath. |
| Approval Order |
Approval Order
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