PMA P970003S095

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S095
Product code: LYJ
Decision date: 2007-12-19
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR CHANGES CONSISTING OF ADDING ?SEROMA? AS AN ADDITIONAL POSSIBLE ADVERSE EVENT IN THE EPILEPSY AND DEPRESSION INFORMATION MODULES AND ADDING A NOTE DESCRIBING POSSIBLE RISKS WITH REPLACING A LARGER PULSE GENERATOR WITH A SMALLER ONE IN THE REVISION/ REPLACEMENT/ REMOVAL MODULE.

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S095
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2007-12-19
Decision code: APPR
Date received: 2007-11-21
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES CONSISTING OF ADDING ?SEROMA? AS AN ADDITIONAL POSSIBLE ADVERSE EVENT IN THE EPILEPSY AND DEPRESSION INFORMATION MODULES AND ADDING A NOTE DESCRIBING POSSIBLE RISKS WITH REPLACING A LARGER PULSE GENERATOR WITH A SMALLER ONE IN THE REVISION/ REPLACEMENT/ REMOVAL MODULE.