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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 P110004
Current Protocol Accepted 04/12/2012
Study Name OSB Lead-Continued f/u of BLAST Placebo 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 Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a non-randomized, multi-center, prospective, single arm clinical


Study Population Description Patients with symptomatic ischemic heart disease due to a single de novo stenotic lesion contained   show the rest ...
Sample Size 131 patients enrolled from up to 15 sites in the USA.


¿ Three-year TVF rate for   show the rest ...
Data Collection Primary Endpoint

Target vessel failure (TVF), defined as cardiac death, target vessel

myocardial infarction (MI) [Q wave   show the rest ...
Followup Visits and Length of Followup Patients will be followed-up for 3 years. Follow-up will be performed at

30 days, 1, 2,   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 74 subjects
Actual Number of Sites Enrolled 12 sites
Patient Followup Rate 93.2% (69/74)
Final Safety Findings The rates [95% Confidence Interval] through 5 years were:

Major Adverse Cardiac Events: 41.7% (30/72) [30.2%,   show the rest ...
Final Effectiveness Findings The rate of cardiac death and MI through 5 years was 29.2% (21/72) [19.0%, 41.1%].
Study Strengths and Weaknesses This study provides longer term (5 years) safety and effectiveness results of Presillion CoCr Coronary   show the rest ...
Recommendations for Labeling Changes A labeling change is recommended to add a summary of the post-approval study results including   show the rest ...

OSB Lead-Continued f/u of BLAST Placebo Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 10/11/2012 10/22/2012 Overdue/Received
one year report 04/12/2013 04/12/2013 On Time
18 month report 10/11/2013 11/15/2013 Overdue/Received
two year report 04/12/2014 06/06/2014 Overdue/Received
Final Report 05/12/2015 05/08/2015 On Time

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