PMA P970003S098
- Device
- VNS THERAPY DEMIPULSE & DEMIPULSE DUO GENERATORS
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S098
- Product code
- LYJ
- Decision date
- 2008-04-03
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR TWO CHANGES TO HE PULSE GENERATOR SOFTWARE TO ELIMINATE A RARE TIMING CONDITION THAT MAY CAUSE THE SOFTWARE WATCHDOG TO, AT THE END OF A MAGNET-INITIATED BURST, REPORT AN ERROR EVEN THOUGH NO SUCH ERROR OCCURRED.
Current openFDA PMA Record#
- Device
- VNS THERAPY DEMIPULSE & DEMIPULSE DUO GENERATORS
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S098
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2008-04-03
- Decision code
- APPR
- Date received
- 2008-02-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR TWO CHANGES TO HE PULSE GENERATOR SOFTWARE TO ELIMINATE A RARE TIMING CONDITION THAT MAY CAUSE THE SOFTWARE WATCHDOG TO, AT THE END OF A MAGNET-INITIATED BURST, REPORT AN ERROR EVEN THOUGH NO SUCH ERROR OCCURRED.