| 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 | Vivistim® System |
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| Generic Name | Stimulator, autonomic nerve, implanted for stroke rehabilitation |
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| Applicant | MicroTransponder, Inc.
2802 Flintrock Trace, Suite 226
Austin, TX 78738 |
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| PMA Number | P210007 |
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| Date Received | 03/02/2021 |
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| Decision Date | 08/27/2021 |
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| Product Code |
QPY |
| Docket Number | 21M-0991 |
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| Notice Date | 09/10/2021 |
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| Advisory Committee |
Physical Medicine |
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| Clinical Trials | NCT03131960
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval the MicroTransponder® Vivistim® Paired VNS System (Vivistim ® System) is intended to be used to stimulate the vagus nerve during rehabilitation therapy in order to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 S003 |
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