FDA-Device2014-10-08Class II
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
St. Jude Medical, Inc.
Hazard
The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
Sold states
Distributed in the states of Texas and Illinois.
Affected count
4 units
Manufactured in
6901 Preston Rd, N/A, Plano, TX, United States
Products
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2719-2014Don't want to check this manually?
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