Vivistim® System
FDA premarket approval P210007/S007 · decided 2025-09-03
Approval details
- PMA number
- P210007
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Vivistim® System
- Generic name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Applicant
- Mobia Medical, Inc.
- Date received
- 2025-08-11
- Decision date
- 2025-09-03
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- QPY
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Austin, TX
- Statement
- undefined
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