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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 P970029 S014
Current Protocol Accepted 01/28/2014
Study Name OSB Lead-PEARL 8.0 New Enrollment Study
Study Status Other
Study Progress Reason Device not marketed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a new enrollment, a prospective single arm study of the

Cardiogenesis PEARL 8.0 Handpiece   show the rest ...
Study Population Description Patients treated with PEARL 8.0 Handpiece, Cardiogenesis TMR

must meet the following inclusion criteria:

¿ Class IV angina

¿ Ejection   show the rest ...
Sample Size Stage 1: 10 patients with no mortalities

Stage 2: 22 patients if 1 mortality in stage   show the rest ...
Data Collection Primary: 30 day mortality

Secondary: Major adverse coronary and cerebrovascular events


  show the rest ...
Followup Visits and Length of Followup 30 days

30 days post procedure

OSB Lead-PEARL 8.0 New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
interim report 10/19/2012 10/19/2012 On Time
one year report 02/21/2013 02/26/2013 Overdue/Received
Interim Report 08/19/2013 08/19/2013 On Time
two year report 02/21/2014 02/21/2014 On Time
three year report 10/01/2016 11/25/2014 On Time

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