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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 P040001
Current Protocol Accepted 10/24/2014
Study Name COAST Study
Study Status Terminated
Study Progress Reason Sponsor withdraws PMA
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 B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description New enrollment, multi-center, prospective cohort
Study Population Description The study population is comprised of patients aged 50 years and older who have lumbar   show the rest ...
Sample Size The sample size is 240 patients and 30 clinical sites
Data Collection The primary endpoint is the Zurich Claudication

Questionnaire (ZCQ) score.

Secondary endpoints include Oswestry Disability Index scores   show the rest ...
Followup Visits and Length of Followup The length of follow-up is 5 years.

Office visits are scheduled preoperatively, and at 6 weeks   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 162 patients were enrolled.
Actual Number of Sites Enrolled 20 sites participated in enrollment.
Patient Followup Rate The follow-up rate of expected subjects is 91.53% and 91.67% at the 24-month and 60-month   show the rest ...
Final Safety Findings Adverse Events (AEs) Summary:

Through August 15, 2014, a total of 814 adverse events were reported   show the rest ...

COAST Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
18 month report 05/20/2008 05/20/2008 On Time
3 year report 11/20/2008 11/20/2008 On Time
4 year report 11/20/2009 11/13/2009 On Time
5 year report 11/20/2010 09/03/2010 On Time
6 year report 11/20/2011 11/12/2010 On Time
interim report 11/20/2011 11/18/2011 On Time
7 year report 11/21/2012 11/13/2012 On Time
reporting changes 01/29/2013 01/29/2013 On Time
8 year report 11/20/2013 11/21/2013 Overdue/Received
9 year report 11/20/2014 11/19/2014 On Time
10 year report 11/20/2015    

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