DevicePMAs@therightstef:P980023_S016 11 Projects
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Approval for changes in component dimensions. The device, as modified, will be marketed under the trade name kentrox sl and is indicated for use in conjunction with a biotronik icd. Currently, data is not available regarding the use of this lead system with icds of other manufacturers. Use of other icds may adversely affect sensing and/or therapy delivery.
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