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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-Enhanced Surveillance


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General
Application Number P100003 / PAS002
Current Plan Approved 05/08/2014
Study Name OSB Lead-Enhanced Surveillance
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description Objectives-To assess safety profile of the secure-C disc under general condition of use. Design- ESS
Study Population Description All patients who have received secure-C
Sample Size N/A
Data Collection Anticipated and un-anticipated adverse events including, but

not limited to major vessel injury, neurological damage, or nerve injury, device migration, removal, revision, and heterotopic codification.

Follow-up Visits and Length of Follow-up 10 years

Assessments: Annual for surgeon surveys, ongoing for the complains, explants and MDRs



OSB Lead-Enhanced Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/29/2013 03/28/2013 On Time
one year report 09/28/2013 09/27/2013 On Time
18 month report 03/29/2014 03/28/2014 On Time
two year report 09/28/2014 09/26/2014 On Time
three year report 09/28/2015 09/30/2015 Overdue/Received
four year report 09/27/2016 09/28/2016 Overdue/Received
five year report 09/27/2017    


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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