FDA.reportPublic FDA data

PMA P970003S238

Device
Demipulse™ Generator; Demipulse Duo™ Generator, AspireSR™ Generator, SenTiva™ Generator; SenTiva Duo™ Generator, Symmetr
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S238
Product code
LYJ
Decision date
2023-02-07
Classification
Neurology
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement
Introduce a new resistance welding system and associated parameter changes utilized in the production of the VNS Therapy System Implantable Pulse Generators.

Current openFDA PMA Record#

Device
Demipulse™ Generator; Demipulse Duo™ Generator, AspireSR™ Generator, SenTiva™ Generator; SenTiva Duo™ Generator, Symmetr
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S238
Product code
LYJ
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Decision date
2023-02-07
Decision code
OK30
Date received
2023-01-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduce a new resistance welding system and associated parameter changes utilized in the production of the VNS Therapy System Implantable Pulse Generators.