PMA P970003S143
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S143
- Product code
- MUZ
- Decision date
- 2012-01-18
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- CHANGES TO THE PARALLEL GAP WELDING STEP DURING THE MANUFACTURING OF THE LEADS FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S143
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2012-01-18
- Decision code
- OK30
- Date received
- 2011-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE PARALLEL GAP WELDING STEP DURING THE MANUFACTURING OF THE LEADS FOR THE DEVICE.