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)
Device | MicroTransponder® Vivistim® Paired VNS™ System (Vivistim® System) |
Generic Name | Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation |
Applicant | MicroTransponder, Inc. |
Date Received | 2021-11-23 |
Decision Date | 2022-02-16 |
PMA | P210007 |
Supplement | S001 |
Product Code | QPY |
Advisory Committee | Physical Medicine |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | MicroTransponder, Inc. 2802 Flintrock Trace, Suite 226 austin, TX 78738 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P210007 | | Original Filing |
S001 |
2021-11-23 |
Real-time Process |
NIH GUDID Devices