PMA P970003S189

Device: VNS THERAPY ASPIRESR GENERATOR; VNS THERAPY PROGRAMMING SOFTWARE
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S189
Product code: MUZ
Decision date: 2016-02-26
Classification: Stimulator, Autonomic Nerve, Implanted (depression)
Generic name: Stimulator, autonomic nerve, implanted (depression)
Approval order statement: Approval for a labeling change to inform clinicians of modified stimulator programming parameters to enhance safety in the use of the device.

Current openFDA PMA Record#

Device: VNS THERAPY ASPIRESR GENERATOR; VNS THERAPY PROGRAMMING SOFTWARE
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S189
Product code: MUZ
Generic name: Stimulator, autonomic nerve, implanted (depression)
Decision date: 2016-02-26
Decision code: APPR
Date received: 2016-01-29
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a labeling change to inform clinicians of modified stimulator programming parameters to enhance safety in the use of the device.