PMA P970003S164
- Device
- VNS THERAPY ACCESSORY PACK
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S164
- Product code
- MUZ
- Decision date
- 2013-09-23
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE IN-LINE TEST RESISTOR THAT IS USED INCONJUNCTION WITH SINGLE PIN PULSE GENERATORS DURING PERIOPERATIVE TROUBLESHOOTING.
Current openFDA PMA Record#
- Device
- VNS THERAPY ACCESSORY PACK
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S164
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2013-09-23
- Decision code
- APPR
- Date received
- 2013-06-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE IN-LINE TEST RESISTOR THAT IS USED INCONJUNCTION WITH SINGLE PIN PULSE GENERATORS DURING PERIOPERATIVE TROUBLESHOOTING.