PMA P970003S100
- Device
- VNS THERAPY PERENNIAFLEX
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S100
- Product code
- LYJ
- Decision date
- 2008-12-19
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR THE FOLLOWING MINOR MODIFICATIONS TO THE APPROVEDMODEL 303 STIMULATION LEAD (THE NEW MODEL TO BE REFERRED TO AS "304"):1) CHANGING THE COIL MATERIAL TO ONE WITH A LOWER TITANIUM TOLERANCE (< 0.01%) TO IMPROVEFATIGUE RESISTANCE;2) CHANGING THE INSULATING MATERIAL TO ONE THAT IS SIMILAR, BUT WITH IMPROVED FATIGUE ANDABRASION RESISTANCE;3) ADDING A CONTROLLED FILLET TO THE ELECTRODE BIFURCATION TO IMPROVE FATIGUE RESISTANCE, AND4) ADDING AN INTERMEDIATE ELECTRODE SIZE (2.5 MM) THAT ALSO OFFERS NERVE COVERAGE >360 DEGREES.
Current openFDA PMA Record#
- Device
- VNS THERAPY PERENNIAFLEX
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S100
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2008-12-19
- Decision code
- APPR
- Date received
- 2008-07-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FOLLOWING MINOR MODIFICATIONS TO THE APPROVEDMODEL 303 STIMULATION LEAD (THE NEW MODEL TO BE REFERRED TO AS "304"):1) CHANGING THE COIL MATERIAL TO ONE WITH A LOWER TITANIUM TOLERANCE (< 0.01%) TO IMPROVEFATIGUE RESISTANCE;2) CHANGING THE INSULATING MATERIAL TO ONE THAT IS SIMILAR, BUT WITH IMPROVED FATIGUE ANDABRASION RESISTANCE;3) ADDING A CONTROLLED FILLET TO THE ELECTRODE BIFURCATION TO IMPROVE FATIGUE RESISTANCE, AND4) ADDING AN INTERMEDIATE ELECTRODE SIZE (2.5 MM) THAT ALSO OFFERS NERVE COVERAGE >360 DEGREES.