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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 P110010 S001
Current Protocol Accepted 08/23/2012
Study Name OSB Lead-Continued 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 Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket study, which is a concurrent, non-randomized, single-arm long lesion (LL) subtrial.   show the rest ...
Study Population Description Patients who met the inclusion/exclusion criteria for the PLATINUM Long Lesion (LL) sub-study, evaluating the   show the rest ...
Sample Size Cohort of 102 patients at 35 sites in the U.S., Europe, IC region and Japan.
Data Collection Target lesion revascularization (TLR) rate, target lesion failure (TLF) rate, target vessel revascularization (TVR) rate,   show the rest ...
Followup Visits and Length of Followup 5 years

18-Month, and 2, 3, 4, 5-Year Follow-Up

Final Study Results
Actual Number of Patients Enrolled 102
Actual Number of Sites Enrolled 23
Patient Followup Rate 86.7% at 5years
Final Safety Findings 12 months

The 12 month primary effectiveness was met. For ITT patients, the 12 month TLF   show the rest ...
Final Effectiveness Findings The main safety and effectiveness endpoint rates through 5 years in the Platinum LL sub-study   show the rest ...
Study Strengths and Weaknesses The Long lesion study met the primary endpoint and provided long term data. However the   show the rest ...
Recommendations for Labeling Changes Labeling change is recommended to reflect the long term data from the post-approval study. The   show the rest ...

OSB Lead-Continued F/U of Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
one year report 06/01/2013 05/23/2013 On Time
two year report 06/01/2014 05/29/2014 On Time
three year report (final report) 11/21/2015 02/23/2016 Overdue/Received

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