PMA P970003S174
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S174
- Product code
- MUZ
- Decision date
- 2015-06-04
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S174
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2015-06-04
- Decision code
- APPR
- Date received
- 2014-11-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.