Vivistim System
FDA premarket approval P210007/S005 · decided 2025-04-24
Approval details
- PMA number
- P210007
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Vivistim System
- Generic name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Applicant
- Mobia Medical, Inc.
- Date received
- 2025-03-04
- Decision date
- 2025-04-24
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- QPY
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Approval for the Site Change Supplement located at the MN Ops Center, 5155 E. River Rd., Suite 409, Fridley, MN, 55421 for receiving, storage, and shipping of the Vivistim System.
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