• 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...


             

Fatigue & Corrosion Testing


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Application Number P000049 S016/ PAS001
Current Plan Approved 03/05/2009
Study Name Fatigue & Corrosion Testing
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, 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 fatigue testing study. The study should assess corrosion potential and passivation layer before and after fatigue testing out to a 10 year equivalent of the device.
Study Population Description N/A
Sample Size N/A
Data Collection This is a fatigue testing study. The study should assess corrosion potential and passivation layer before and after fatigue testing out to a 10 year equivalent of the device.
Follow-up Visits and Length of Follow-up N/A
Final Study Results
Interim Safety Information N/A, This is a bench testing study.




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

-
-