PMA P970003S200

Device: DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR.
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S200
Product code: LYJ
Decision date: 2016-11-23
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: Approval for a manufacturing site located at Cyberonics Latam S.L.R., Edificio B49, 51 Ave 0, Zona Franca Coyol, Coyol - Alajuela, Costa Rica.

Current openFDA PMA Record#

Device: DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR.
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S200
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2016-11-23
Decision code: APPR
Date received: 2016-05-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Cyberonics Latam S.L.R., Edificio B49, 51 Ave 0, Zona Franca Coyol, Coyol - Alajuela, Costa Rica.