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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P050023
Most Recent Protocol Version Approved 08/10/2006
Study Name TUPOS LV
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 Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-site post-approval study involving previously implanted Tupos LV/ATx patients who participated   show the rest ...
Study Population Description The study population consists of previously implanted Tupos LV/ATx patients who participated in the OPTION   show the rest ...
Sample Size The post-approval study required following the existing OPTION Tupos LV/ATx patient cohort and did not   show the rest ...
Data Collection The post-approval study will report patient mortality, left ventricular (LV) lead capture thresholds and specific   show the rest ...
Followup Visits and Length of Followup The patients are followed every 3-months for a period of three years. The patient's follow-up   show the rest ...
Final Study Results
Actual Number of Patients Enrolled Of the original 129 OPTION CRT/ATx patients successfully implanted with a Tupos LV/ATx, 49 patients   show the rest ...
Actual Number of Sites Enrolled 19 sites
Patient Followup Rate Of the original 129 OPTION CRT/ATx patients successfully implanted with a Tupos LV/ATx, 49 patients   show the rest ...
Final Safety Findings A total of 119 measurements in 47 patients were performed at routine and interim follow-ups.   show the rest ...
Study Strengths and Weaknesses Weakness: Of the 49 patients enrolled in the post-approval study, 10 withdrew consent, 4 died,   show the rest ...
Recommendations for Labeling Changes None


TUPOS LV Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
2 year report TUPOS 08/08/2008 08/08/2008 On Time

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