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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-Registry Study

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Application Number P080030 / PAS003
Current Plan Approved 07/21/2015
Study Name OSB Lead-Registry Study
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a prospective, single쳌]arm, multicenter registry of subjects implanted with GTS100 stents. Subjects will be followed for at least 3 months and up to 12 months from the date of implantation. The study will determine the rate

of sight쳌]threatening adverse events for up to 6 months after

surgery. The specific question this study will address is: What are the 3쳌]and 6쳌] month sight쳌]threatening adverse event rates after implanting the study device in conjunction with cataract surgery and the corresponding 95% confidence interval?

Study Population Description Subjects with implantation of GTS100 in conjunction with cataract surgery.
Sample Size Not specified
Data Collection Sight쳌]threatening adverse events
Follow-up Visits and Length of Follow-up 3 months or until adverse events related to the study procedure are resolved or stable,

OSB Lead-Registry Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 12/24/2012 12/26/2012 Overdue/Received
one year report 06/25/2013 06/25/2013 On Time
18 month report 12/24/2013 01/27/2014 Overdue/Received
two year report 06/25/2014 06/24/2014 On Time
three year report 06/25/2015 06/24/2015 On Time

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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