H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: unknown indigo handpiece.H6: codes b17 and c20 applicable for handpiece.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
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