Clearance Summary
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR received FDA 510(k) clearance under submission number K032561, sponsored by Medtronic Vascular. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-09-11.
- Submission: K032561
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5880
- Decision date: 2003-09-11
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.