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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-Long-Term F/U of IDE COC36 patients

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Application Number P070026 S004/ PAS001
Current Plan Approved 03/10/2015
Study Name OSB Lead-Long-Term F/U of IDE COC36 patients
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 Multi-center, cohort study
Study Population Description Patients will be enrolled from the IDE study
Sample Size It is anticipated that up to 80 subjects from the IDE study implanted

with the 36 mm device will consent to participate.

Data Collection Device revision is the primary endpoint; secondary endpoints

include Harris Hip Scores and radiographic findings.

Follow-up Visits and Length of Follow-up Patients will be followed for 10 post-operative years,

These subjects will be evaluated at the time of consent

(approximately 5 to 7 years post-op), again at a minimum 8 year follow-up interval, and finally at a minimum 10 year follow-up interval.

OSB Lead-Long-Term F/U of IDE COC36 patients Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/01/2013 10/01/2013 On Time
one year report 04/02/2014 04/02/2014 On Time
18 month report 10/01/2014 10/01/2014 On Time
two year report 04/02/2015 03/31/2015 On Time
three year report 04/01/2016 04/01/2016 On Time
four year report 04/01/2017    
five year report 04/01/2018    

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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