MicroTransponder® Vivistim® Paired VNS System
FDA premarket approval P210007/S004 · decided 2025-01-24
Approval details
- PMA number
- P210007
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MicroTransponder® Vivistim® Paired VNS System
- Generic name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Applicant
- Mobia Medical, Inc.
- Date received
- 2025-01-15
- Decision date
- 2025-01-24
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- QPY
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Austin, TX
- Statement
- undefined
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