PMA P210007S003

Device: MicroTransponder Vivistim Paired VNS System (Vivistim System)
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S003
Product code: QPY
Decision date: 2024-08-21
Classification: Physical Medicine
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Approval order statement: Your supplement requested approval for changes to the device software to fix several bugs, incorporate patient and clinician feedback, and strengthen the password requirements of the device login.

Current openFDA PMA Record#

Device: MicroTransponder Vivistim Paired VNS System (Vivistim System)
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S003
Product code: QPY
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Decision date: 2024-08-21
Decision code: APPR
Date received: 2024-06-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Your supplement requested approval for changes to the device software to fix several bugs, incorporate patient and clinician feedback, and strengthen the password requirements of the device login.