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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-Newly Enrolled Study

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Study Status Progress Adequate
Application Number P110021 / PAS002
Date Current Protocol Accepted 09/13/2013
Study Name OSB Lead-Newly Enrolled Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Retrospective/Prospective Cohort Study
Study Population Description High risk patients undergoing transcatheter heart valve replacement therapy

with severe symptomatic native aortic stenosis.

Sample Size A total of 5000 subjects combined for P110021 & P100041 patients enrolled into the STS/ACC TVT Registry in all US sites.
Data Collection Two primary endpoints: stroke at 30 days and 1 year
Follow-up Visits and Length of Follow-up 5 years

Discharge, 30 days and 1 year as well follow-up at 2 years, 3 years, 4 years

and 5 years

OSB Lead-Newly Enrolled Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/19/2013 04/25/2013 Overdue/Received
one year report 10/19/2013 10/15/2013 On Time
18 month report 04/19/2014 04/17/2014 On Time
two year report 10/19/2014 10/15/2014 On Time
three year report 10/19/2015 10/13/2015 On Time
four year report 10/18/2016 10/12/2016 On Time
five year report 10/18/2017 10/19/2017 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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