Last updated on August 2018

Product Surveillance Registry (PSR) Platform Base Protocol

Brief description of study

The purpose of the PSR platform is to provide continuing evaluation and periodic reporting ofsafety and effectiveness of market-released products for their intended use. PSR data will support post-market surveillance activities initiated by Medtronic and post-approval studies directed by a government and/or a regulatory authority. Conducting product surveillance in large populations over time provides an effective means of assessing product performance, patient safety and clinical outcomes. Product surveillance is the systematic collection, analysis, and interpretation of performance data, as well as its dissemination and application. The PSR platform provides an extensive repository of data for conducting signal detection activities for identification of emerging patient safety or performance issues. It provides a mechanism for gaining an increased understanding of the relationship between a product’s performance and clinical outcomes, as well as improving patient safety by identifying potential negative performance trends more quickly. The PSR data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Clinical Study Identifier: TX210445

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