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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
Current Protocol Accepted 05/11/2012
Study Name OSB Lead-Continued F/u of Premarket Cohort
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Workhorse (WH) Trial is a prospective, randomized, controlled, single blind, multicenter, non-inferiority trial

Small Vessel (SV)   show the rest ...
Study Population Description Continued follow-up of the premarket cohorts:

WH - Subjects with a maximum of 2 de novo   show the rest ...
Sample Size WH 1,532

SV 94

PK 20-30

Approximately 85 sites in the US, 50 in Europe, 15 in the   show the rest ...
Data Collection WH target lesion failure (TLF), MI, or death at 12 months

SV - TLF at   show the rest ...
Followup Visits and Length of Followup Through 5 years post-procedure

12 months, 18 months, 2 years, 3 years, 4 years, and 5   show the rest ...
Final Study Results
Actual Number of Patients Enrolled -WH Randomized Clinical Trial: 1530

-SV Subtrial: 94

-PK Subtrial: 22

Actual Number of Sites Enrolled Actual number of study sites enrolled

-Workhorse (WH) Randomized Clinical Trial: 132

-Small Vessel (SV) Subtrial: 23

-Pharmacokinetics   show the rest ...
Patient Followup Rate -WH Randomized Clinical Trial: 94%

-SV Subtrial: 93.3%

-PK Subtrial: 100%

Final Safety Findings -WH Randomized Clinical Trial: At the 5 year follow-up both the PROMUS Element and PROMUS/Xience   show the rest ...
Final Effectiveness Findings -WH Randomized Clinical Trial: the 12-month target lesion failure (TLF) primary endpoint was met, indicating   show the rest ...
Study Strengths and Weaknesses -WH Randomized Clinical Trial: This was a large (>1,500 subjects) randomized clinical trial with a   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 Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 05/22/2012 05/21/2012 On Time
one year report 11/21/2012 11/14/2012 On Time
18 month report 06/01/2013 05/23/2013 On Time
two year report 11/21/2013 11/21/2013 On Time
three year report 11/21/2014 11/21/2014 On Time
final report 09/18/2015 11/16/2015 Overdue/Received

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