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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 P110010 S001
Most Recent Protocol Version Approved 08/24/2012
Study Name PROMUS Element Plus US PAS
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 Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, open-label, multi-center registry study
Study Population Description PLATINUM-like patients, including at least 200 patients treated with PROMUS Element Plus long lesion stents   show the rest ...
Sample Size 2,689 consecutive, consented patients from up to 65 sites in order to attain 906 PLATINUM   show the rest ...
Data Collection Primary: Cardiac death or myocardial infarction rate through 12 months post stent implantation among all   show the rest ...
Followup Visits and Length of Followup 5 years

30- days, 180-days, and annually through 5 years post intervention



PROMUS Element Plus US PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
3 month report 08/31/2012 09/20/2012 Overdue/Received
6 month report 11/30/2012 11/16/2012 On Time
9 month report 06/01/2013 06/03/2013 Overdue/Received
one year report 06/01/2013 06/03/2013 Overdue/Received
18 month report 11/30/2013 11/20/2013 On Time
two year report 06/01/2014    
three year report 06/01/2015    
four year report 05/31/2016    
five year report 05/31/2017    

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