PMA P210007S015

Device: Vivistim® System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S015
Product code: QPY
Decision date: 2026-09-16
Classification: Physical Medicine
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Approval order statement: Mobia Medical has replaced their supplier for the Lead Connector Boot component of the Implantable Lead of the Vivistim® Paired VNS System, transitioning from Trelleborg to ProMed.

Current openFDA PMA Record#

Device: Vivistim® System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S015
Product code: QPY
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Decision date: 2026-09-16
Decision code: OK30
Date received: 2026-08-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Mobia Medical has replaced their supplier for the Lead Connector Boot component of the Implantable Lead of the Vivistim® Paired VNS System, transitioning from Trelleborg to ProMed.