PMA P970003S170

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S170
Product code: MUZ
Decision date: 2016-02-12
Classification: Stimulator, Autonomic Nerve, Implanted (depression)
Generic name: Stimulator, autonomic nerve, implanted (depression)
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 facility, in which the site will perform the final assembly, packaging, storing, and distribution of the Implantable Pulse Generators and the Lead Finals.

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S170
Product code: MUZ
Generic name: Stimulator, autonomic nerve, implanted (depression)
Decision date: 2016-02-12
Decision code: APPR
Date received: 2014-04-28
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 facility, in which the site will perform the final assembly, packaging, storing, and distribution of the Implantable Pulse Generators and the Lead Finals.