PULSE/PULSE DUO GENERATOR-MODEL 102/102R
FDA premarket approval P970003/S188 · decided 2016-02-19
Approval details
- PMA number
- P970003
- Supplement
- S188
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PULSE/PULSE DUO GENERATOR-MODEL 102/102R
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2015-11-24
- Decision date
- 2016-02-19
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for labeling changes being made to the Model 102/102R Technical Information Chapter of the VNS Therapy Physicians Manual involving the addition/correction of information concerning generator performance exceptions.
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510(k) clearances by this applicant
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| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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