VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC)
FDA premarket approval P970003/S162 · decided 2013-07-10
Approval details
- PMA number
- P970003
- Supplement
- S162
- Supplement type
- Real-Time Process
- Trade name
- VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2013-04-22
- Decision date
- 2013-07-10
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- 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).
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| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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