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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 NCDR ICD Registry Study


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General
Application Number P010031 S232/ PAS001
Current Plan Approved 06/29/2012
Study Name OSB Lead-REVERSE NCDR ICD Registry Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective Cohort Study
Study Population Description Patients meeting the expanded CRT-D indication criteria are eligible to participate the analysis cohort.
Sample Size At least 1500 patients from US implanted with a Medtronic CRT-D device who meet the expanded indication criteria will be included in the analyses. A minimum of 500 patients with QRS duration will be included in the primary objective analysis.
Data Collection 5-year survival probability for patients implanted with a Medtronic CRT-D who meet the expanded indication criteria within percent precision.
Follow-up Visits and Length of Follow-up 5-years post-implant.



Reconciliation of mortality for patients identified through the NCDR® ICD Registry¿ will be completed monthly through 5-years post-implant.



OSB Lead-REVERSE NCDR ICD Registry Study 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 03/29/2013 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 07/29/2016 08/01/2016 Overdue/Received
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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