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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 P110013 S005
Most Recent Protocol Version Approved 02/21/2013
Study Name Resolute Integrity PAS Newly Enrolled
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort 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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The sponsor will use the ongoing PAS that was ordered for P110013, which is a   show the rest ...
Study Population Description Patients who met the inclusion/exclusion criteria for the RESOLUTE INTEGRITY US - XL, evaluating the   show the rest ...
Sample Size The observed event rate for the primary endpoints is assumed to be 3.5% so a   show the rest ...
Data Collection Primary Endpoint

The primary endpoint for all patients enrolled in this study (overall and sub-study) is   show the rest ...
Followup Visits and Length of Followup 5 years

Frequency of Follow-up Assessments

For XL Sub-study patients: at 30 days, 6 months, 24 months   show the rest ...


Resolute Integrity PAS Newly Enrolled Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 08/23/2013 11/07/2013 Overdue/Received
one year report 02/22/2014 02/18/2014 On Time
18 month report 08/23/2014    
two year report 02/22/2015    
three year report 02/22/2016    
four year report 02/21/2017    
five year report 02/21/2018    

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