VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC)
FDA premarket approval P970003/S169 · decided 2014-07-02
Approval details
- PMA number
- P970003
- Supplement
- S169
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2014-04-04
- Decision date
- 2014-07-02
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR A CHANGE TO THE PRINTED CIRCUIT BOARD ASSEMBLYMANUFACTURING DESIGN REQUIREMENT FOR VOLTAGE MEASUREMENT ACCURACY AND TOLERANCE ASSOCIATED WITH ITS ELECTRICAL TESTING.
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