NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S048 · decided 2003-10-22
Approval details
- PMA number
- P970003
- Supplement
- S048
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2003-09-17
- Decision date
- 2003-10-22
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR A CHANGE TO THE PRECAUTION REGARDING BRADYCARDIA AND/OR ASYSTOLE.
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| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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