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U.S. Department of Health and Human Services

Post-Approval Studies

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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

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General
Application Number P040051
Current Protocol Accepted 04/22/2011
Study Name Stelkast Surpass Active PAS
Study Status Progress Inadequate
Study Progress Reason Follow-up rate below 80%
General Study Protocol Parameters
Study Design Active Surveillance
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Active surveillance supplemented by prospective multi-center cohort study



Study Population Description Patients implanted with the Stelkast Surpass Acetabular System
Sample Size 320 patients active surveillance, 20 patients prospective multi-center cohort



Patient sites: sites for the active surveillance   show the rest ...
Data Collection Study endpoints include device related adverse events, device revision, removal. reoperations, and supplemental fixation.



  show the rest ...
Followup Visits and Length of Followup Annual



Length of follow up: 10 Years


Stelkast Surpass Active PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 10/22/2011 10/20/2011 On Time
one year report 04/22/2012 05/04/2012 Overdue/Received
18 month report 12/21/2012 12/21/2012 On Time
two year report 04/22/2013 04/23/2013 Overdue/Received
three year report 05/22/2014 05/22/2014 On Time

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