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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 P100049
Current Protocol Accepted 06/22/2012
Study Name OSB Lead-Extended f/u of premarket cohort
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective, multi-center, single arm clinical study that will be conducted in   show the rest ...
Study Population Description Subjects ages > 18 or Age of Majority according to Law in states or countries   show the rest ...
Sample Size The study will continue to follow the 100 patients available in the IDE pivotal study.   show the rest ...
Data Collection Primary safety endpoint:

The primary safety endpoint is the rate of occurrence for serious device and   show the rest ...
Followup Visits and Length of Followup The length of follow up will be 60 months post-implantation.

The follow up assessments will   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 100
Actual Number of Sites Enrolled 14
Patient Followup Rate 85/100 (85%)
Final Safety Findings 10 serious adverse events were reported in 7 subjects. The serious SAE rate was 7.0%   show the rest ...
Final Effectiveness Findings 83.3% of subjects had at least a 50% reduction in their 60 month total GERD-HRQL   show the rest ...
Study Strengths and Weaknesses Strengths: This study had a high five year follow-up rate of 85 out of 100   show the rest ...
Recommendations for Labeling Changes None. There are no new safety or effectiveness concerns since the approval of the current labeling

OSB Lead-Extended f/u of premarket cohort Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 09/20/2012 09/20/2012 On Time
one year report 03/22/2013 03/26/2013 Overdue/Received
18 month report 09/20/2013 09/20/2013 On Time
two year report 03/22/2014 03/18/2014 On Time
three year report-final report 03/22/2015 12/15/2014 On Time

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