| Device | Vivistim System |
|---|---|
| Generic Name | Stimulator, autonomic nerve, implanted for stroke rehabilitation |
| Applicant | MicroTransponder, Inc. 2802 Flintrock Trace, Suite 226 Austin, TX 78738 |
| PMA Number | P210007 |
| Supplement Number | S005 |
| Date Received | 03/04/2025 |
| Decision Date | 04/24/2025 |
| Product Code | QPY |
| Advisory Committee | Physical Medicine |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Expedited Review Granted? | No |
| Combination Product | No |
| Approval Order Statement Approval for the Site Change Supplement located at the MN Ops Center, 5155 E. River Rd., Suite 409, Fridley, MN, 55421 for receiving, storage, and shipping of the Vivistim System. | |
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P210007/S005 review time is faster than 100% of similar devices* and 71.5% faster than the median.
* Similar Devices - Devices that share the same advisory committee and supplement type.
| Suppl. # | Suppl. Type & Reason | Approval Order Statement | Received | Decision |
|---|---|---|---|---|
| S002 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) 180-day supplement, which requested approval for modifications to device labeling. based upon the information submitted, the pma supplement is approved. |
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| S001 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for updating the wireless transmitter from model 2000 to model 2100 to accommodate an obsolete part and accompanying changes to the software (saps model 4001) and implantable pulse generator (model 1001) |
||
| Original | Original |
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. |
