PMA P970003S142
- Device
- VNS THERAPY SYSTEM PULSE GENERATORS
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S142
- Product code
- MUZ
- Decision date
- 2011-12-23
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- TWO REVISIONS TO THE SOFTWARE USED IN THE AUTOMATED FUNCTIONAL TEST SYSTEM (AFT) FOR THE VNS THERAPY SYSTEM PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM PULSE GENERATORS
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S142
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2011-12-23
- Decision code
- OK30
- Date received
- 2011-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TWO REVISIONS TO THE SOFTWARE USED IN THE AUTOMATED FUNCTIONAL TEST SYSTEM (AFT) FOR THE VNS THERAPY SYSTEM PULSE GENERATORS.