PMA P970003S102

Device: NEUROCYBERNETIC PROSTHESIS (NCP) PROGRAMMING WAND
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S102
Product code: LYJ
Decision date: 2008-11-12
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR LABELING CHANGES THAT INCLUDE THE ADDITION OF CONFIRMATORY TESTING INFORMATION, STRENGTHENING OF WARNINGS, AND FORMATTING REVISIONS.

Current openFDA PMA Record#

Device: NEUROCYBERNETIC PROSTHESIS (NCP) PROGRAMMING WAND
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S102
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2008-11-12
Decision code: APPR
Date received: 2008-10-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES THAT INCLUDE THE ADDITION OF CONFIRMATORY TESTING INFORMATION, STRENGTHENING OF WARNINGS, AND FORMATTING REVISIONS.