510(k) Report

Devices descending from K920567

2 later devices reach Models 3987 and 3988 Resume Lead for PNS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032561Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation…Medtronic Vascular20031—
+2K040568Polyether Urethane Material Change in Neurostimulation LeadsMedtronic Vascular20040—