POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS

Stimulator, Spinal-cord, Implanted (pain Relief)

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Polyether Urethane Material Change In Neurostimulation Leads.

Pre-market Notification Details

Device IDK040568
510k NumberK040568
Device Name:POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant MEDTRONIC VASCULAR 710 MEDTRONIC PARKWAY NE Minneapolis,  MN  55432 -5604
ContactDoug Atkins
CorrespondentDoug Atkins
MEDTRONIC VASCULAR 710 MEDTRONIC PARKWAY NE Minneapolis,  MN  55432 -5604
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-04
Decision Date2004-03-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00673978926452 K040568 000
00885074473703 K040568 000

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