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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 P070012
Current Protocol Accepted 10/23/2007
Study Name MAVErIC II Long Term Study
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 Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of the MAVErIC Phase I and II studies was to demonstrate the safety   show the rest ...
Study Population Description This device is indicated for use, in conjunction with a Medtronic Vascular embolic protection system,   show the rest ...
Sample Size 399 patients
Data Collection The protocol defined primary endpoint for each phase of the trial was the cumulative incidence   show the rest ...
Followup Visits and Length of Followup Patient follow up occurring at 30 days for all 1500 patients enrolled in the study   show the rest ...
Final Study Results
Actual Number of Patients Enrolled MAVErIC I study: 99 patients; MAVErIC II study: 399 patients
Actual Number of Sites Enrolled NA
Patient Followup Rate 69%
Final Safety Findings Adjudicated all-cause death rate at 3-years postprocedure was 21.8% (87/399). The total rate of myocardial   show the rest ...
Study Strengths and Weaknesses Strengths: The sponsor did enroll and follow-up additional subjects then was originally asked for by   show the rest ...
Recommendations for Labeling Changes Labeling was not updated since the device is no longer marketed.


MAVErIC II Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month final report 04/23/2008 05/05/2008 On Time

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