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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 P050023
Current Protocol Accepted 08/10/2006
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description In this study patients are enrolled 1-30 days after successful implantation of the Corox OTW   show the rest ...
Study Population Description Study Population: Patients implanted with the Corox OTW Steriod LV lead.
Sample Size 250 subjects, at up to 100 sites
Data Collection The evaluation of safety is based on the analysis of Corox over-the-wire Steroid lead related   show the rest ...
Followup Visits and Length of Followup The patients will be followed for a period of three years. The specific visits that   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 221
Actual Number of Sites Enrolled 34
Patient Followup Rate 59% through three years
Final Safety Findings Observations. A total of 23 (10.4%) of the enrolled patients have reported a Corox OTW   show the rest ...
Final Effectiveness Findings

At all scheduled follow-up intervals and interim visits, the CRT system provided appropriate biventricular pacing   show the rest ...
Study Strengths and Weaknesses

The study results they provide little long term follow-up of the lead. Overall the lead   show the rest ...
Recommendations for Labeling Changes Updated to include the long-term post-approval study data and findings.


Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report COROX/TUPOS LV 08/10/2007 08/08/2007 On Time
2 year report COROX 08/08/2008 08/08/2008 On Time
3 year report COROX 08/10/2009 08/05/2009 On Time
4 year report COROX 08/10/2010 08/10/2010 On Time
5 year report 08/10/2011 08/10/2011 On Time
Final Report 03/06/2012 03/06/2012 On Time

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