PMA P970003S050
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S050
- Product code
- MUZ
- Decision date
- 2005-07-15
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- APPROVAL FOR THE VNS THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE ADJUNCTIVE LONG-TERM TREATMENT OF CHRONIC OR RECURRENT DEPRESSION FOR PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE EXPERIENCING A MAJOR DEPRESSIVE EPISODE AND HAVE NOT HAD AN ADEQUATE RESPONSE TO FOUR OR MORE ADEQUATE ANTIDEPRESSANT TREATMENTS.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P970003S050B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S050
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2005-07-15
- Decision code
- APPR
- Date received
- 2003-10-27
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE VNS THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE ADJUNCTIVE LONG-TERM TREATMENT OF CHRONIC OR RECURRENT DEPRESSION FOR PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE EXPERIENCING A MAJOR DEPRESSIVE EPISODE AND HAVE NOT HAD AN ADEQUATE RESPONSE TO FOUR OR MORE ADEQUATE ANTIDEPRESSANT TREATMENTS.