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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-SureScan Pacing System


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General
Application Number P980035 S277/ PAS001
Current Plan Approved 12/19/2012
Study Name OSB Lead-SureScan Pacing System
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21


OSB Lead-SureScan Pacing System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/16/2013 07/12/2013 On Time
one year report 01/15/2014 02/05/2014 Overdue/Received
18 month report 08/16/2014 08/07/2014 On Time
two year report 02/07/2015 02/09/2015 Overdue/Received
30 month report 08/07/2015 08/07/2015 On Time
3 year report 02/07/2016 02/08/2016 Overdue/Received
42 month report 08/07/2016 08/05/2016 On Time
4 year report 02/06/2017    


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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