PMA P970003S109

Device: VNS THERAPY SYSTEM/NCP/VNS PULSE GENERATORS
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S109
Product code: LYJ
Decision date: 2010-05-18
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR A LABELING MODIFICATION REGARDING THE INTERNAL CLOCK RESET IN THE MODEL 100, 101, 102 AND 102R IMPLANTED PULSE GENERATORS (IPGS).

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM/NCP/VNS PULSE GENERATORS
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S109
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2010-05-18
Decision code: APPR
Date received: 2010-04-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING MODIFICATION REGARDING THE INTERNAL CLOCK RESET IN THE MODEL 100, 101, 102 AND 102R IMPLANTED PULSE GENERATORS (IPGS).