PMA P210007S002

Device: Vivistim® System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S002
Product code: QPY
Decision date: 2024-03-25
Classification: Physical Medicine
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Approval order 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.

Current openFDA PMA Record#

Device: Vivistim® System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S002
Product code: QPY
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Decision date: 2024-03-25
Decision code: APPR
Date received: 2024-01-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.