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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-REVERSE Product Surveillance Registry


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General
Application Number P010031 S232/ PAS002
Current Plan Approved 09/17/2012
Study Name OSB Lead-REVERSE Product Surveillance Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective cohort study
Study Population Description All adult patients treated with a Medtronic CRT-D device, meeting the expanded indication with QRS duration < 150ms, enrolled into Medtronic¿s Product Surveillance Registry.
Sample Size 216 investigation sites, 500 patients
Data Collection ¿To estimate the 3-year survival probability of freedom from centrally adjudicated heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration < 150ms.

¿To estimate the 3-year survival probability of freedom from centrally adjudicated heart failure event or all cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration < 150ms.

Follow-up Visits and Length of Follow-up 3 years, with the potential to be extended out to 5-years

every 6 months from implant through a minimum of 3-years



OSB Lead-REVERSE Product Surveillance Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/03/2012 10/03/2012 On Time
one year report 04/04/2013 04/01/2013 On Time
18 month report 10/03/2013 10/02/2013 On Time
two year report 04/04/2014 03/20/2014 On Time
three year report 04/04/2015 03/30/2015 On Time
four year report 04/03/2016 04/01/2016 On Time
five year report 04/03/2017    


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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