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

Post-Approval Studies

  • Print
  • Share
  • E-mail
-

Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

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

Show All Studies
Export to ExcelExport to Excel
General
Application Number P050039
Most Recent Protocol Version Approved 12/09/2010
Study Name Long Term
Study Status Revised/Replaced Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center, open label clinical study. Up to ten (10) centers around   show the rest ...
Study Population Description The study population is comprised of patients implanted in the United States and potentially outside   show the rest ...
Sample Size prospective and retrospective cohort, active surveillance, up to 10 clinical sites in prospective and retrospective   show the rest ...
Data Collection The first phase of the study extending through 5 years of patient follow-up, will consist   show the rest ...
Followup Visits and Length of Followup The length of patient follow-up is 10 years. Follow-up visits will occur pre-operatively, immediately post-operatively,   show the rest ...


Long Term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 07/04/2008 07/03/2008 On Time
2 year report 07/04/2009 07/01/2009 On Time
3 year report 07/04/2010 07/06/2010 Overdue

Show All Studies

-
-