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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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Generalizability Study


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General
Application Number H080002 / PAS002
Current Plan Approved 09/24/2013
Study Name Generalizability Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
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 is a prospective, observational, non-randomized, multi-center study. The study purpose is to confirm the short-term hemodynamic effectiveness results achieved by real world providers are equivalent to the historical control established in the IDE study. Where the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation will be assessed.
Study Population Description Consecutive subjects at each site will be invited to participate in the study if they meet the indication for the device. This include the eExistence of a full right ventricular outflow tract conduit that was equal to or greater than 16 mm in diameter when originally implanted, and dysfunction ight ventricular outflow tract conduits with a clinical indication for intervention, including moderate or severe regurgitation or stenosis with and ight ventricular outflow tract gradient of at least 35 mmHg.
Sample Size 100 patients, 10-15 sites
Data Collection The primary endpoint is the percentage of subjects with acceptable hemodynamic function at six months post-implant.
Follow-up Visits and Length of Follow-up Follow-up of the clinical endpoints will be conducted at baseline (pre-implant), discharge from the hospital, at six months post-implant, one year, and annually thereafter, until the patient has been followed for five years or until the device has been explanted.
Final Study Results
Interim Safety Information No safety data is available for this study.


Generalizability Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/26/2010 07/19/2010 On Time
1 year report 01/25/2011 01/26/2011 Overdue/Received
18 month report 07/26/2011 07/26/2011 On Time
2 year report 01/25/2012 01/25/2012 On Time
request to move reporting dates 07/11/2012 07/11/2012 On Time
30 month report 07/25/2012 07/25/2012 On Time
3 year report 07/26/2013 07/26/2013 On Time
4 year report 07/26/2014 07/24/2014 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
20993-0002

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

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