RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR— 510(k) K032561

Clearance details

Applicant

Medtronic Vascular

Product code

Code GZB

Device class

Class 2

Regulation

21 CFR 882.5880

Advisory panel

Neurology

Date received

2003-08-20

Decision date

2003-09-11

Decision

Substantially Equivalent

Clearance type

Special

Location

Miinneapolis, MN, US

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Death

4

Injury

1,879

Other

2

Total

1,885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →