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Product Surveillance Registry (PSR)

  • Study HIC#:1303011669REG
  • Last Updated:07/15/2021

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry 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.

  • GenderBoth
  • Start Date05/09/2013
  • End Date01/31/2030

Trial Purpose and Description

Provide continuing evaluation and periodic reporting of safety and effectiveness of market-released Medtronic products for their intended use.

Eligibility Criteria

Inclusion Criteria:

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive or be treated with an eligible Medtronic product
  • Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Exclusion Criteria:

  • Patient who is, or will be, inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Sub-Investigator

For more information about this study, contact the Help us Discover team on: