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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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Long Term Study


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General
Study Status Completed
Application Number P030004 / PAS001
Date Current Protocol Accepted 07/21/2005
Study Name Long Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is to continue following for 3 years post-embolization those patients from the PMA study who received Onyx LES but did not have their AVM completely, surgically resected
Study Population Description This device is indicated for presurgical embolization of brain arteriovenous malformations. The post-approval study includes patients from the PMA study who received Onyx LES but did not have their AVM completely, surgically resected
Sample Size 17
Data Collection MRI/CT scan results and adverse events
Follow-up Visits and Length of Follow-up Annually for 3 years
Interim or Final Data Summary
Interim Safety Information Study is completed. See Final results
Actual Number of Patients Enrolled 17
Actual Number of Sites Enrolled Not mentioned
Patient Follow-up Rate 53%
Final Safety Findings There were 14 adverse events occurred in 4 Onyx patients and a total of 10 adverse events occurred in 5 n-BCA treated patients who have completed the minimum 3 year follow-up.
Study Strengths & Weaknesses Prospective f-u up to 3-year. No control, only limited to part of IDE subjects.
Recommendations for Labeling Changes None


Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 07/21/2006 07/20/2006 On Time
2 year report 07/21/2007 07/23/2007 Overdue/Received
3 year report 10/07/2008 10/03/2008 Overdue


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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