• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail

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.

Learn more...


OSB Lead-Clinical Study

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Application Number P860057 S042/ PAS001
Current Plan Approved 11/03/2009
Study Name OSB Lead-Clinical Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a single arm prospective multi-site study, to be conducted at up to 25 sites, inside and outside of the United States. This is a prospective, single-arm, multi-center study to be conducted in

the US, and outside the US. This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years
Study Population Description Study Population: Patients eligible for mitral valve replacement. Indication: It is intended for patients who require replacement of their diseased, damaged or malfunctioning native or prosthetic aortic valve and whose prognosis without aortic valve replacement is unacceptably poor.
Sample Size 225 patiens at up to 20 sites
Data Collection Primary safety endpoints include thromboembolism, hemorrhage, perivascular leak, and endocarditis. Secondary safety endpoints include blood count data, death, explant, reoperation, non-structural valve dysfunction, structural valve deterioration, and hemodynamic data obtained through echocardiography.
Follow-up Visits and Length of Follow-up Follow-up visits will occur postoperatively, at discharge, at 6 months, one year, and annually thereafter, for 8 years.
Final Study Results
Interim Safety Information No safety data is available for this study.

OSB Lead-Clinical Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/05/2010 08/04/2010 On Time
1 year report 11/05/2010 11/02/2010 On Time
18 month report 05/07/2011 05/09/2011 Overdue/Received
2 year report 11/05/2011 11/04/2011 On Time
3 year report 08/04/2012 08/01/2012 On Time
4 year report 05/06/2013 06/25/2013 Overdue/Received
5 year report 05/06/2014 05/05/2014 On Time
6 year report 05/06/2015 04/30/2015 On Time
7 year report 05/05/2016 05/02/2016 On Time
8 year report 05/05/2017    
Final Report 08/04/2017    

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

Related Links