PMA P210007S006

Device: Vivistim® System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S006
Product code: QPY
Decision date: 2025-05-30
Classification: Physical Medicine
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Approval order statement: Approval for proposed manufacturing changes, consisting of changes in suppliers of selected components internal to the ViviStim Implantable Pulse Generator (IPG). These component suppliers were previously qualified by the main contract manufacturer and included on their Approved Suppliers List for the supply of raw materials and unfinished components, and they are now qualified to perform additional manufacturing steps that were previously performed by the main contract manufacturer.

Current openFDA PMA Record#

Device: Vivistim® System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S006
Product code: QPY
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Decision date: 2025-05-30
Decision code: OK30
Date received: 2025-05-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for proposed manufacturing changes, consisting of changes in suppliers of selected components internal to the ViviStim Implantable Pulse Generator (IPG). These component suppliers were previously qualified by the main contract manufacturer and included on their Approved Suppliers List for the supply of raw materials and unfinished components, and they are now qualified to perform additional manufacturing steps that were previously performed by the main contract manufacturer.