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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
Study Name Continued F/u of Premarket and OUS Cohort
Study Status Study Pending
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The 38 mm Length Group is designed as a prospective analysis of the pooled data   show the rest ...
Study Population Description Subjects enrolled in the Global Resolute Clinical Program
Sample Size 223 subjects (Consists of patients from 38 mm sub studies of R-US (N=114) and R-Asia (N=109))
Data Collection Primary Endpoints

Stent Thrombosis rates from 12-24, 24-36, 36-48 and 48-60 months

Cardiac Death/TV MI annual rates   show the rest ...
Followup Visits and Length of Followup Patient Contact (assessed by telephone, email and/or office visit):

Annually 2, 3 years (R-Asia)*

Annually 2,   show the rest ...


Continued F/u of Premarket and OUS Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
one year report 02/22/2014 03/31/2014 On Time
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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