PMA P970003S058

Device: VNS THERAPY SYSTEM, MODEL 302
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S058
Product code: LYJ
Decision date: 2005-09-29
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR CHANGES TO THE MODEL 302 LEAD PHYSICIAN'S MANUAL CLARIFYING INFORMATION REGARDING HANDLING TO AVOID DAMAGE TO THE LEAD AND HELICAL ELECTRODES.

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM, MODEL 302
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S058
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2005-09-29
Decision code: APPR
Date received: 2005-07-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE MODEL 302 LEAD PHYSICIAN'S MANUAL CLARIFYING INFORMATION REGARDING HANDLING TO AVOID DAMAGE TO THE LEAD AND HELICAL ELECTRODES.