PMA P210007

Device
Vivistim Pair VNS System
Applicant
Mobia Medical, Inc.
PMA number
P210007
Supplement
S001
Product code
QPY
Decision date
2026-06-18
Generic name
Stimulator, autonomic nerve, implanted for stroke rehabilitation
Approval order statement
Approval for supplier change

Current openFDA PMA Record#

Device
Vivistim Pair VNS System
Applicant
Mobia Medical, Inc.
PMA number
P210007
Supplement
S014
Product code
QPY
Generic name
Stimulator, autonomic nerve, implanted for stroke rehabilitation
Decision date
2026-06-18
Decision code
OK30
Date received
2026-05-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for supplier change