PMA P210007S008

Device: Vivistim® Paired VNS System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S008
Product code: QPY
Decision date: 2026-02-26
Classification: Physical Medicine
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Approval order statement: Approval for expansion of MN Ops Center capabilities, including component receiving inspection & acceptance, in-house manufacturing and software installation of Stroke Application & Programming software (SAPS), routine software/firmware upgrades, and device relabeling.

Current openFDA PMA Record#

Device: Vivistim® Paired VNS System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S008
Product code: QPY
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Decision date: 2026-02-26
Decision code: APPR
Date received: 2025-11-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for expansion of MN Ops Center capabilities, including component receiving inspection & acceptance, in-house manufacturing and software installation of Stroke Application & Programming software (SAPS), routine software/firmware upgrades, and device relabeling.