PMA P970003S155
- Device
- VNS THERAPY PULSE/PULSE DUO GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S155
- Product code
- MUZ
- Decision date
- 2013-02-25
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE ELECTRICAL TEST SYSTEM (ETS) SOFTWARE USED IN PRODUCTION.
Current openFDA PMA Record#
- Device
- VNS THERAPY PULSE/PULSE DUO GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S155
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2013-02-25
- Decision code
- APPR
- Date received
- 2012-11-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE ELECTRICAL TEST SYSTEM (ETS) SOFTWARE USED IN PRODUCTION.