Description of the risk mitigation element

Reference no: EM133429167

Assignment:

Amplatzer^TM Amulet^TM Left Atrial Appendage

Description of the risk mitigation elements put into place for your product (4-5 slides)

For drugs/biologics: Search the FDA REMs and EMA RMP pages to find key information about your product's US and European Risk Mitigation strategies.

You can also look at individual serious adverse events (ICSRs) reported from use with your product using EMA's eudravigilance portal. Have any notable events occurred with use of this product that might merit a change to the REMs or RMP?

For medical devices: Search the TPLC database to examine the product's post-market studies (see PMAs), recall history, and device problems.

Are there any patterns in the safety information that lead you to believe that the QMS/post-market surveillance of the product should be revised?

Reference no: EM133429167

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