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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-New Enrollment Study


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General
Application Number P110039 / PAS001
Current Plan Approved 03/15/2013
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is multi-center prospective cohort. .
Study Population Description The sample size is 70 patients. Sample size and power calculations are provided in the protocol. The study population will be comprised of patients inside the United States who sign an informed consent and receive the device in the post-market environment.
Sample Size The sample size is 70 patients. Sample size and power calculations are provided in the protocol. The study population will be comprised of patients inside the United States who sign an informed consent and receive the device in the post-market environment.
Data Collection Study endpoints include pain response, medication use and quality of life.
Follow-up Visits and Length of Follow-up Patients will undergo clinical examination at the time of enrollment and one month and 3 months

post-treatment. The total length of follow-up is three months.


OSB Lead-New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/18/2013 06/18/2013 Overdue/Received
one year report 10/18/2013 10/28/2013 Overdue/Received
18 month report 04/18/2014 05/07/2014 Overdue/Received
two year report 10/18/2014 11/05/2014 Overdue/Received
three year report 10/18/2015 11/06/2015 Overdue/Received
four year report 10/17/2016    
five year report 10/17/2017    


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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