PMA P970003S186
- Device
- VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S186
- Product code
- MUZ
- Decision date
- 2015-11-20
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- USE OF A NEW HELIUM LEAK TESTER IN THE MANUFACTURING PROCESS OF PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S186
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2015-11-20
- Decision code
- OK30
- Date received
- 2015-10-09
- Supplement type
- 30-Day Notice
- Approval order statement
- USE OF A NEW HELIUM LEAK TESTER IN THE MANUFACTURING PROCESS OF PULSE GENERATORS.