MicroTransponder Vivistim Paired VNS System (Vivistim System)
FDA premarket approval P210007/S003 · decided 2024-08-21
Approval details
- PMA number
- P210007
- Supplement
- S003
- 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
- 2024-06-06
- Decision date
- 2024-08-21
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- QPY
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Your supplement requested approval for changes to the device software to fix several bugs, incorporate patient and clinician feedback, and strengthen the password requirements of the device login.
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