PMA P970003S162
- Device
- VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC)
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S162
- Product code
- MUZ
- Decision date
- 2013-07-10
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- APPROVAL FOR A CHANGE TO THE TRANSMIT TO RECEIVE REFRACTORY TIMEWHICH IS A SPECIFICATION OF THE APPLICATION SPECIFIC INTEGRATED CIRCUIT (ASIC) USED IN MODEL 103/104/105 VNS GENERATORS AND THE IMPLEMENTATION OF A SCREENING TEST TO BE PERFORMED AT THEVENDOR (ON SEMICONDUCTOR).
Current openFDA PMA Record#
- Device
- VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC)
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S162
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2013-07-10
- Decision code
- APPR
- Date received
- 2013-04-22
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR A CHANGE TO THE TRANSMIT TO RECEIVE REFRACTORY TIMEWHICH IS A SPECIFICATION OF THE APPLICATION SPECIFIC INTEGRATED CIRCUIT (ASIC) USED IN MODEL 103/104/105 VNS GENERATORS AND THE IMPLEMENTATION OF A SCREENING TEST TO BE PERFORMED AT THEVENDOR (ON SEMICONDUCTOR).