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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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Elution


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General
Study Status Completed
Application Number /
Requirement Number		 P080006 / PAS001
Date Original Protocol Accepted 04/07/2009
Date Current Protocol Accepted 04/07/2009
Study Name Elution
Device Name MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
Clinical Trial Number(s) NCT00271544 
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study will provide the complete elution profile data for the tip and ring at 50 rpm and 100 rpm from all the lots that are manufactured during the first post-approval year. Based on the elution data provided in this report, a decision on the rotation speed and/or the acceptance criteria for the tip and ring will be made by the Agency. Elution profile data for the tip and ring at 50 rpm and 100 rpm from all the lots that are manufactured during the first post-approval year
Study Population N/A
Sample Size N/A
Key Study Endpoints Elution profile data for the tip and ring at 50 rpm and 100 rpm from all the lots that are manufactured during the first post-approval year
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 N/A This is a bench testing study.
Study Strengths & Weaknesses N/A
Recommendations for Labeling Changes N/A


Elution Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 04/07/2010 01/29/2010 Overdue


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

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