PMA P970003S146
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S146
- Product code
- MUZ
- Decision date
- 2013-11-26
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- REQUESTED APPROVAL FOR A LABELING UPDATE TO INCLUDE THE RESULTS OF THE D-21 POST APPROVALSTUDY.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S146
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2013-11-26
- Decision code
- APPR
- Date received
- 2012-03-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- REQUESTED APPROVAL FOR A LABELING UPDATE TO INCLUDE THE RESULTS OF THE D-21 POST APPROVALSTUDY.