Vivistim® System
FDA premarket approval P210007/S002 · decided 2024-03-25
Approval details
- PMA number
- P210007
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Vivistim® System
- Generic name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Applicant
- Mobia Medical, Inc.
- Date received
- 2024-01-23
- Decision date
- 2024-03-25
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- QPY
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Austin, TX
- Statement
- The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for modifications to device labeling. Based upon the information submitted, the PMA supplement is approved.
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