PMA P970003S145
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S145
- Product code
- MUZ
- Decision date
- 2012-02-06
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- INTRODUCTION OF WORK INSTRUCTIONS TO ALLOW REWORK AND REPLACEMENT OF COMPONENTS IN THE VNS THERAPY SYSTEM.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S145
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2012-02-06
- Decision code
- OK30
- Date received
- 2012-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INTRODUCTION OF WORK INSTRUCTIONS TO ALLOW REWORK AND REPLACEMENT OF COMPONENTS IN THE VNS THERAPY SYSTEM.