PMA P210007
- Device
- Vivistim® System
- Applicant
- Mobia Medical, Inc.
- PMA number
- P210007
- Supplement
- S001
- Product code
- QPY
- Decision date
- 2026-04-10
- Generic name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Approval order statement
- Approval for supplier change
Current openFDA PMA Record#
- Device
- Vivistim® System
- Applicant
- Mobia Medical, Inc.
- PMA number
- P210007
- Supplement
- S013
- Product code
- QPY
- Generic name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Decision date
- 2026-04-10
- Decision code
- OK30
- Date received
- 2026-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for supplier change