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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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Application Number P040034 / PAS001
Current Plan Approved 04/07/2005
Study Name Duraseal
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The PAS is a prospective, randomized, single-blinded (patients), multi-center study to further characterize the DuraSeal Sealant as compared to "standard of care" in patients scheduled for cranial surgery that entails a dural incision.
Study Population Description This device is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.The study population includes subjects scheduled for clean, elective cranial surgery that entail dural incisions that are closed primarily with sutures with or without autologous duraplasty. To be eligible for the study, subjects had to be between 18 and 75 years of age, scheduled for an elective cranial procedure entailing a dural incision, and provided informed consent on an IRB approved consent form, and intra-operatively, there must have been evidence of non watertight closure after primary dural closure, either spontaneously or upon Valsalva maneuver, at 20 cm water for 5-10 seconds.
Sample Size 250 patients; approximately 25 centers
Data Collection The primary outcome is the incidence of neurosurgical complications related to unplanned intervention (i.e., minimally invasive procedures) or return to the operating room. The secondary outcomes are 1) the incidence of post-operative surgical site infections within 30 days post-operation defined as (a) Superficial Incisional, (b) Deep Incisional, (c) Organ/Space; and 2) the presence or absence of CSF leaks within 30 days post-operation as determined from clinical diagnosis.
Follow-up Visits and Length of Follow-up Patients are followed for 30 days after treatment, and are evaluated clinically at discharge and at 30 days post-procedure.
Final Study Results
Interim Safety Information Study is completed. See Final Results
Number of Patients 237 patients
Number of Sites 17 centers
Follow-up Rate 98.30%
Safety Findings There were 18 primary endpoint complications in 16 subjects: 9 happened in 8 patients in the DuraSeal group of which 6 (66.7%) were procedure related, 1 treatment related (11.1%), 1 not related and 1 unable to determine. Nine happened in 8 patients in the standard of care group: 7 (77.7%) were procedure related and 2 were treatment related (22.2%). All reported neurosurgical complications for the DuraSeal Sealant group are anticipated and expected. The incidence and nature of the complications that have been reported are consistent with the type and complexity of the procedures performed.
Strengths & Weaknesses High follow up rate. Randomized design.
Label Changes The sponsor updated the labeling to reflect the post-approval study results prior to FDA completing review of the final report. The lableing changes were also reviewed by FDA and the labeling does reflect the study results.

Duraseal Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 10/06/2005 10/11/2005 Overdue/Received
1 year report 04/07/2006 04/06/2006 On Time
18 month report 10/06/2006 10/13/2006 Overdue/Received
2 year report 04/07/2007 04/09/2007 Overdue/Received
30 month report 12/12/2007 12/12/2007 On Time
3 year report 04/06/2008 04/08/2008 Overdue/Received
4 year report 04/06/2009 04/07/2009 Overdue/Received
5 year report 04/06/2010 12/23/2009 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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