PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105
FDA premarket approval P970003/S176 · decided 2015-03-04
Approval details
- PMA number
- P970003
- Supplement
- S176
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2014-12-09
- Decision date
- 2015-03-04
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR AN UPDATE TO THE LONGEVITY MANUFACTURING REQUIREMENTASSOCIATED WITH THE MODEL 102/102R AND MODEL 105 GENERATORS.
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