f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Tag Alert


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General
Study Status Completed
Application Number /
Requirement Number		 P870056 S015/ PAS001
Date Original Protocol Accepted 08/22/2003
Date Current Protocol Accepted  
Study Name Tag Alert
Device Name CARPENTIER-EDWARDS BIOPROSTHESES, MODELS 2625 (AORTIC) & 6625 (MITRAL), AND CARPENTIER-EDWARDS BIOPROSTHETIC VALVED COND
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a real-time aging study of a part of the packaging for the device and will consist of validation of the Sensitech brand TagAlert Temperature Alarm Indicator (high and low) with programming over time
Study Population N/A
Sample Size N/A
Key Study Endpoints The study will collect data for the validation of the Sensitech brand TagAlert Temperature Alarm Indicator (high and low) with programming over time
Follow-up Visits and Length of Follow-up N/A
Interim or Final Data Summary
Interim Results Study completed, see final results
Actual Number of Patients Enrolled N/A
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings All units passed real-time testing
Study Strengths & Weaknesses N/A
Recommendations for Labeling Changes N/A


Tag Alert Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
4th Year final PAS report 03/24/2008 03/24/2008 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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