NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S032 · decided 2001-05-10
Approval details
- PMA number
- P970003
- Supplement
- S032
- Supplement type
- Normal 180 Day 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
- 2001-03-23
- Decision date
- 2001-05-10
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT STERITEC, INC., ATHENS, TEXAS, AS WELL AS LABELING PROCESS AND PACKAGING CHANGES, AND A COMBINED MODEL PHYSICIAN'S MANUAL.
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