VNS THERAPY SYSTEM
FDA premarket approval P970003/S071 · decided 2006-10-17
Approval details
- PMA number
- P970003
- Supplement
- S071
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VNS THERAPY SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2006-08-24
- Decision date
- 2006-10-17
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE LABELING HARMONIZATION AND MODULARIZATION FOR PHYSICIAN PULSE GENERATOR AND LEAD LABELING: 1) THE ADDITION OF A MANUAL ENTITLED, ?REVISION/REPLACEMENT/REMOVAL PROCEDURE MANUAL?. 2) THE INCORPORATION OF THE PHYSICIAN?S MANUAL FOR THE MODEL 303 LEAD INTO THE HARMONIZED LABELING WHICH INCLUDES THE ADDITION OF THE MODULAR PHYSICIAN?S MANUAL ENTITLED, ?TECHNICAL INFORMATION ? VNS THERAPY PERENNIA MODEL 303 LEAD?. 3) REVISIONS TO THE ?IMPLANTATION PROCEDURE? M
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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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