Clearance Summary
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS received FDA 510(k) clearance under submission number K063080, sponsored by Advanced Neuromodulation Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-12-12.
- Submission: K063080
- Applicant / Sponsor: Advanced Neuromodulation Systems
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5880
- Decision date: 2006-12-12
Classification & Regulation
This clearance is catalogued under FDA product code GZB and 21 CFR 882.5880, within the Neurology review panel as a Class II device.