VNS THERAPY SYSTEM, MODEL 302
FDA premarket approval P970003/S058 · decided 2005-09-29
Approval details
- PMA number
- P970003
- Supplement
- S058
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VNS THERAPY SYSTEM, MODEL 302
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2005-07-20
- Decision date
- 2005-09-29
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR CHANGES TO THE MODEL 302 LEAD PHYSICIAN'S MANUAL CLARIFYING INFORMATION REGARDING HANDLING TO AVOID DAMAGE TO THE LEAD AND HELICAL ELECTRODES.
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