Clearance Summary
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL received FDA 510(k) clearance under submission number K952459, sponsored by Medtronic Vascular. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1995-08-30.
- Submission: K952459
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5880
- Decision date: 1995-08-30
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.