Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
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Date of event; corrected information ; initial mdr inadvertently omitted information known prior to submission.Date received by manufacturer; initial mdr inadvertently included incorrect information known prior to submission.The actual value should be (b)(6) 2023.Per internal procedure, this value is to be updated to the date the correction mdr is submitted, therefore the date populated in g3 is the date the report was submitted and not the date of the manufacturer's awareness.
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