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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 P060028
Current Protocol Accepted 02/12/2016
Study Name OSB Lead-MemoryGel and Shape Combined Cohort
Study Status Progress Adequate
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 Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a new enrollment prospective (10-year) post-approval cohort study to collect additional post-approval clinical   show the rest ...
Study Population Description Women who receive Mentor?s MemoryGel and MemoryShape breast implants for the purpose of primary or   show the rest ...
Sample Size The study will enroll 2,518 women who receive Memory Gel and MemoryShape Breast Implants for   show the rest ...
Data Collection Safety Endpoints to be evaluated are as follows: Local complications, connective tissue diseases, rheumatologic and   show the rest ...
Followup Visits and Length of Followup Patients will be followed for 10 years.

Frequency of Follow-up Assessments

MemoryGel and Memory Shape Breast Implant   show the rest ...

OSB Lead-MemoryGel and Shape Combined Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 12/13/2013 12/09/2013 On Time
one year report 06/14/2014 06/10/2014 On Time
18 month report 12/13/2014 12/08/2014 On Time
two year report 06/14/2015 06/03/2015 On Time
3 year report 08/12/2016 08/10/2016 On Time
42 month report 02/12/2017    
4 year report 08/13/2017    
54 month report 02/12/2018    
5 year report 08/13/2018    

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