VNS THERAPY PULSE GENERATOR (DEMIPULSE AND DEMIPULSE DUO)
FDA premarket approval P970003/S156 · decided 2013-02-07
Approval details
- PMA number
- P970003
- Supplement
- S156
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VNS THERAPY PULSE GENERATOR (DEMIPULSE AND DEMIPULSE DUO)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2013-01-17
- Decision date
- 2013-02-07
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- MANUFACTURING CHANGE FOR THE THERAPY GENERATORS.
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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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