- Device
- MicroTransponder® Vivistim® Paired VNS™ System (Vivistim® System)
- Applicant
- Mobia Medical, Inc.
- PMA number
- P210007
- Supplement
- S001
- Product code
- QPY
- Generic name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Decision date
- 2022-02-16
- Decision code
- APPR
- Date received
- 2021-11-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- 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)