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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.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P070014 S010
Current Protocol Accepted 07/11/2014
Study Name OSB Lead-CONTINUUM Long Lesion
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a single-arm, non-randomized, prospective, multi-center international study in subjects (>=22 years of age)   show the rest ...
Study Population Description The study population will be comprised of subjects who present with lifestyle-limiting claudication or ischemic   show the rest ...
Sample Size 170 patients; 20 sites
Data Collection The primary safety endpoint is freedom from death at 12 months post-procedure. The primary effectiveness   show the rest ...
Followup Visits and Length of Followup Subjects will undergo a clinical evaluation at baseline (prior to study procedure), prior to hospital   show the rest ...

OSB Lead-CONTINUUM Long Lesion Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 06/23/2011 06/23/2011 On Time
one year report 02/13/2012 02/08/2012 On Time
two year report 02/13/2013 02/13/2013 On Time
three year report 02/13/2014 02/14/2014 Overdue/Received
four year report 02/13/2015 02/18/2015 Overdue/Received
five year report 02/13/2016 02/16/2016 Overdue/Received

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