PMA P970003S014

Device: NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S014
Product code: LYJ
Decision date: 1999-01-20
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: Approval for labeling changes being made to the Model 100 NCP PUlse Generator Physician's Manual, the Model 300 NCP Bipolar Lead Physician's Manual, and the Patient's Manual for the NCP System.

Current openFDA PMA Record#

Device: NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S014
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 1999-01-20
Decision code: APPR
Date received: 1998-12-21
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes being made to the Model 100 NCP PUlse Generator Physician's Manual, the Model 300 NCP Bipolar Lead Physician's Manual, and the Patient's Manual for the NCP System.