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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Cont FU of Premarket Cohort

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Study Status Completed
Application Number P110023 / PAS002
Date Current Protocol Accepted 03/07/2012
Study Name OSB Lead-Cont FU of Premarket Cohort
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
Interim or Final Data Summary
Actual Number of Patients Enrolled 287
Actual Number of Sites Enrolled 51
Patient Follow-up Rate 86%
Final Safety Findings Stent fracture rate at 3 years:0.9%

(Other key safety endpoints are subsumed in primary effectiveness endpoint (See below).

Final Effect Findings CDTLR at 3 years: 30%

Major amputation rate at 3 years: 0.8% Death rate at 30 days: 0%

Study Strengths & Weaknesses The main study limitations derive from the fact that the study population consisted of subjects from the premarket cohort. Premarket studies are typically characterized by providers who are exceptionally skilled, and are therefore likely to provide relatively good results. However, this study is just one component of a two-component PAS requirement. The other component, which is not yet completed, utilizes newly enrolled patients obtained from different sites, which are more likely to be typical of the general population of providers.
Recommendations for Labeling Changes yes

OSB Lead-Cont FU of Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/05/2012 08/24/2012 On Time
one year report 03/07/2013 02/26/2013 On Time
18 month report-final report 09/05/2013 10/02/2013 Overdue/Received

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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