VNS THERAPY SYSTEM/NCP/VNS PULSE GENERATORS
FDA premarket approval P970003/S109 · decided 2010-05-18
Approval details
- PMA number
- P970003
- Supplement
- S109
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VNS THERAPY SYSTEM/NCP/VNS PULSE GENERATORS
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2010-04-19
- Decision date
- 2010-05-18
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR A LABELING MODIFICATION REGARDING THE INTERNAL CLOCK RESET IN THE MODEL 100, 101, 102 AND 102R IMPLANTED PULSE GENERATORS (IPGS).
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