PMA P970003S166

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S166
Product code: MUZ
Decision date: 2014-05-09
Classification: Stimulator, Autonomic Nerve, Implanted (depression)
Generic name: Stimulator, autonomic nerve, implanted (depression)
Approval order statement: APPROVAL FOR LABELING THAT DESCRIBES THE CONDITIONS UNDER WHICH MAGNETIC RESONANCE IMAGING (MRI) CAN BE USED WHEN RESIDUAL VNS LEADS OR LEAD FRAGMENTS (ABANDONED LEADS) REMAIN IN THE BODY.

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S166
Product code: MUZ
Generic name: Stimulator, autonomic nerve, implanted (depression)
Decision date: 2014-05-09
Decision code: APPR
Date received: 2013-11-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING THAT DESCRIBES THE CONDITIONS UNDER WHICH MAGNETIC RESONANCE IMAGING (MRI) CAN BE USED WHEN RESIDUAL VNS LEADS OR LEAD FRAGMENTS (ABANDONED LEADS) REMAIN IN THE BODY.