PMA P970003S106
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S106
- Product code
- LYJ
- Decision date
- 2009-03-06
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR CHANGING THE TRADE NAME OF THE VNS THERAPY PERENNIA MODEL 303 LEAD TO VNS THERAPY PERENNIADURA MODEL 303 LEAD.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S106
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2009-03-06
- Decision code
- APPR
- Date received
- 2009-02-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGING THE TRADE NAME OF THE VNS THERAPY PERENNIA MODEL 303 LEAD TO VNS THERAPY PERENNIADURA MODEL 303 LEAD.