Vivistim® System
FDA premarket approval P210007/S006 · decided 2025-05-30
Approval details
- PMA number
- P210007
- Supplement
- S006
- 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
- 2025-05-01
- Decision date
- 2025-05-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QPY
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Approval for proposed manufacturing changes, consisting of changes in suppliers of selected components internal to the ViviStim Implantable Pulse Generator (IPG). These component suppliers were previously qualified by the main contract manufacturer and included on their Approved Suppliers List for the supply of raw materials and unfinished components, and they are now qualified to perform additional manufacturing steps that were previously performed by the main contract manufacturer.
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