NEUROCYBERNETIC PROSTHESIS (NCP) PROGRAMMING WAND
FDA premarket approval P970003/S102 · decided 2008-11-12
Approval details
- PMA number
- P970003
- Supplement
- S102
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NEUROCYBERNETIC PROSTHESIS (NCP) PROGRAMMING WAND
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2008-10-01
- Decision date
- 2008-11-12
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR LABELING CHANGES THAT INCLUDE THE ADDITION OF CONFIRMATORY TESTING INFORMATION, STRENGTHENING OF WARNINGS, AND FORMATTING REVISIONS.
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