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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-ProMRI ICD/CRT-D System Home Monitorin


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General
Study Status Progress Adequate
Application Number P050023 S094/ PAS001
Date Current Protocol Accepted 07/21/2017
Study Name OSB Lead-ProMRI ICD/CRT-D System Home Monitorin
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description All subjects implanted with a ProMRI ICD/CRT-D system enabled with Home Monitoring® in the United States will be retrospectively assessed for VF episodes detected by the ICD/CRT-D following MRI exposure.
Study Population Description All subjects implanted with ProMRI ICD/CRT-D system and

enabled with Home Monitoring® in the United States will be retrospectively assessed through a de-identified Home Monitoring database.

Sample Size 25 subjects with a post-MRI VF episode have been identified

or the 5-years post-approval time point has been reached, whichever comes first.

Data Collection Primary Endpoint 1: Characterize VF Detection Following

MR Exposure

Primary Endpoint 2: Left Ventricular Pacing Threshold Secondary Endpoint 1: Characterize Workflow Compliance Following MR Exposure

Secondary Endpoint 2: Left Ventricular Sensing Attenuation

Follow-up Visits and Length of Follow-up 25 subjects with a post-MRI VF episode have been identified

or the 5-years post-approval time point has been reached, whichever comes first.



OSB Lead-ProMRI ICD/CRT-D System Home Monitorin Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/02/2016 11/01/2016 On Time
one year report 05/02/2017 05/02/2017 On Time
18 month report 11/02/2017 11/02/2017 On Time
two year report 05/02/2018    
three year report 05/02/2019    
four year report 05/01/2020    
five year report 05/01/2021    
final report 11/02/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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