PMA P210007S007

Device
Vivistim® System
Applicant
Mobia Medical, Inc.
PMA number
P210007
Supplement
S007
Product code
QPY
Decision date
2025-09-03
Classification
Physical Medicine
Generic name
Stimulator, autonomic nerve, implanted for stroke rehabilitation
Approval order statement
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Current openFDA PMA Record#

Device
Vivistim® System
Applicant
Mobia Medical, Inc.
PMA number
P210007
Supplement
S007
Product code
QPY
Generic name
Stimulator, autonomic nerve, implanted for stroke rehabilitation
Decision date
2025-09-03
Decision code
OK30
Date received
2025-08-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
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