MicroTransponder® Vivistim® Paired VNS System (Vivistim® System)
FDA premarket approval P210007/S001 · decided 2022-02-16
Approval details
- PMA number
- P210007
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MicroTransponder® Vivistim® Paired VNS System (Vivistim® System)
- Generic name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Applicant
- Mobia Medical, Inc.
- Date received
- 2021-11-23
- Decision date
- 2022-02-16
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- QPY
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Austin, TX
- 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)
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