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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-DuraSeal Exact Spine Sealant System

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Application Number P080013 / PAS001
Current Plan Approved 02/03/2016
Study Name OSB Lead-DuraSeal Exact Spine Sealant System
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: Estimate the rates of post-operative CSF leak, deep surgical site infection and neurological SAEs within 90 days for DuraSeal Exact Spine Sealant and to compare these rates to the corresponding rates for Control. Design: a multi-center, non-randomized, Post Approval study with a prospective treatment arm and a retrospective control arm.

Study Population Description For the retrospective controls (standard of care), subjects with fewer than 45 days of follow-up will be considered incomplete.

Sample Size The DuraSeal Exact Spine Sealant prospective treatment arm will enroll up to 489 subjects in order to obtain a total of 402 evaluable subjects with 90 day follow-up data.
Data Collection The primary endpoint is the occurrence of post-operative CSF leaks within 90 days after the spine surgical procedure.

A CSF leak is defined as a CSF fistula or a pseudomeningocele* confirmed by clinical examination or diagnostic testing (i.e., MRI or CT) whether or not treatment such as surgical repair or drainage is required.

* Pseudomeningocele noted on a diagnostic test must be confirmed by the study investigator

Secondary endpoints are the occurrence of the following events (within 90 days following the surgical procedure):

Deep Surgical Site Infections (DSSI) as defined per the CDC guidelines

All neurological SAEs

Follow-up Visits and Length of Follow-up For retrospective controls (standard of care), a patient will be considered completed if there is follow-up of at least 45 days.

New study sites that do not have 90 day standard of care visits will enroll prospective subjects only (DuraSeal and/or Control). This would allow new sites to contribute subjects prospectively inside the study window (60 to 120 days), and allow control over follow-up compliance.

OSB Lead-DuraSeal Exact Spine Sealant System Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month interim report 07/06/2010 07/06/2010 On Time
1 year report 09/04/2010 11/12/2010 Overdue/Received
2 year report 09/04/2011 09/21/2011 Overdue/Received
6 month report 03/04/2012 03/02/2012 On Time
3 year report 09/03/2012 10/01/2012 Overdue/Received
4 year report 09/03/2013 09/19/2013 Overdue/Received
5 year report 09/03/2014 09/02/2014 On Time
6 year report 09/03/2015 08/20/2015 On Time
7 year report/final report 10/31/2016    

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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