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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-Short-Mid-Term F/u of New COC36 patients

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Application Number P070026 S004/ PAS002
Current Plan Approved 03/12/2015
Study Name OSB Lead-Short-Mid-Term F/u of New COC36 patients
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multi-center, prospective cohort
Study Population Description Newly enrolled patients with 36mm Ceramax┬┐ Ceramic on Ceramic

Total Hip System

Sample Size 170 patients

Data Collection Study endpoints include device revision, Harris Hip Scores and radiographic findings.
Follow-up Visits and Length of Follow-up 5 years

OSB Lead-Short-Mid-Term F/u of New 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
quarterly report 10/24/2015 10/13/2015 On Time
quarterly report 01/24/2016 01/19/2016 On Time
three year report 04/01/2016 04/01/2016 On Time
quarterly report 07/20/2016 07/20/2016 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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