PMA P970003S176
- Device
- PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S176
- Product code
- MUZ
- Decision date
- 2015-03-04
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE LONGEVITY MANUFACTURING REQUIREMENTASSOCIATED WITH THE MODEL 102/102R AND MODEL 105 GENERATORS.
Current openFDA PMA Record#
- Device
- PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S176
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2015-03-04
- Decision code
- APPR
- Date received
- 2014-12-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE LONGEVITY MANUFACTURING REQUIREMENTASSOCIATED WITH THE MODEL 102/102R AND MODEL 105 GENERATORS.