FDA-Device2023-11-08Class II
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Medtronic Neuromodulation
Hazard
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
Sold states
US: MO, FL, TX, WA
Affected count
14 units
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0217-2024Don't want to check this manually?
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