VNS THERAPY SYSTEM MODEL 250 PROGRAMMING SOFTWARE, VERSION 8.0
FDA premarket approval P970003/S116 · decided 2010-11-23
Approval details
- PMA number
- P970003
- Supplement
- S116
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS THERAPY SYSTEM MODEL 250 PROGRAMMING SOFTWARE, VERSION 8.0
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2010-09-27
- Decision date
- 2010-11-23
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR DESIGN MODIFICATIONS AND ASSOCIATED LABELING CHANGES TO THE PROGRAMMING SOFTWARE, MODEL 250 PROGRAMMING SOFTWARE.
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