NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S035 · decided 2001-09-04
Approval details
- PMA number
- P970003
- Supplement
- S035
- 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
- 2001-08-27
- Decision date
- 2001-09-04
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR A CHANGE TO THE LABELING TO ADD A CONTRAINDICATION REGARDING THE USE OF DIATHERMY ON PATIENTS IMPLANTED WITH THE NEUROCYBERNETIC PROSTHESIS (NCP(R)) SYSTEM.
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