PMA P970003S089

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S089
Product code: LYJ
Decision date: 2007-10-11
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR THE ADDITION OF INSTRUCTIONS TO THE TROUBLESHOOTING SECTION IN THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.1 AND MINOR CORRESPONDING CHANGES TO THE HANDHELD COMPUTER CONNECTION INSTRUCTIONS (HP JORNADA, DELL AXIM X5 AND X50).

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S089
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2007-10-11
Decision code: APPR
Date received: 2007-09-10
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF INSTRUCTIONS TO THE TROUBLESHOOTING SECTION IN THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.1 AND MINOR CORRESPONDING CHANGES TO THE HANDHELD COMPUTER CONNECTION INSTRUCTIONS (HP JORNADA, DELL AXIM X5 AND X50).