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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-5 year long term (IDE)

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Study Status Terminated
Application Number P040040 / PAS001
Date Current Protocol Accepted 09/07/2007
Study Name OSB Lead-5 year long term (IDE)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population 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 will provide long-term follow-up of forty-three subjects from the premarket cohort that have been designated as High Risk.
Study Population Description This device is indicated for use in patients with a complex VSD of significant size to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.
Sample Size 43 patients, 21 sites
Data Collection Safety endpoints include adverse events.
Follow-up Visits and Length of Follow-up Annual office visits were required out to 5 years.
Interim or Final Data Summary
Interim Safety Information The study was terminated early due a low follow-up rate
Actual Number of Patients Enrolled 43
Actual Number of Sites Enrolled 38
Patient Follow-up Rate 24%
Final Safety Findings A total of 35 overall events were reported in 20 of 43 subjects (46.5%). The most frequently reported event was hypotension which was reported in 11.6% of subjects (5 reports in 5 of 43 subjects).
Study Strengths & Weaknesses Strengths: Lessons learned on requesting for long term follow-up consent at tiem of IDE enrollment

Weaknesses: Extremely low follow-up of the cohort.
Recommendations for Labeling Changes No labeling changes were recommended.

OSB Lead-5 year long term (IDE) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 03/07/2008 03/05/2008 On Time
1 year report 09/07/2008 09/08/2008 Overdue/Received
18 Month Report 03/05/2009 03/05/2009 On Time
2 year report 09/07/2009 10/15/2009 Overdue

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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