PMA P210007S005

Device: Vivistim System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S005
Product code: QPY
Decision date: 2025-04-24
Classification: Physical Medicine
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Approval order statement: Approval for the Site Change Supplement located at the MN Ops Center, 5155 E. River Rd., Suite 409, Fridley, MN, 55421 for receiving, storage, and shipping of the Vivistim System.

Current openFDA PMA Record#

Device: Vivistim System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S005
Product code: QPY
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Decision date: 2025-04-24
Decision code: APPR
Date received: 2025-03-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the Site Change Supplement located at the MN Ops Center, 5155 E. River Rd., Suite 409, Fridley, MN, 55421 for receiving, storage, and shipping of the Vivistim System.