• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

OSB Lead-Elution


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Application Number P080006 / PAS001
Current Plan Approved 04/07/2009
Study Name OSB Lead-Elution
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 Design Description 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 Description N/A
Sample Size N/A
Data Collection 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
Final Study Results
Interim Safety Information Study completed, see final results
Number of Patients N/A
Number of Sites N/A
Follow-up Rate N/A
Safety Findings N/A This is a bench testing study.
Strengths & Weaknesses N/A
Label Changes N/A


OSB Lead-Elution Schedule

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

Related Links

-
-