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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 06/14/2013
Study Name OSB Lead-Post-Approval PMA Cohort Study (PACS)
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The MemoryShape Core Study is a post-approval cohort study to assess safety and effectiveness in   show the rest ...
Study Population Description Women with Mentor¿s MemoryShape Breast Implants as indicated for primary augmentation, revision augmentation, primary reconstruction,   show the rest ...
Sample Size A total of 955 subjects have been enrolled in MemoryShape Core Study. The protocol does   show the rest ...
Data Collection During the 10-year follow-up period, long-term safety of the Implants will continue to be measured   show the rest ...
Followup Visits and Length of Followup Subjects will be seen by the investigator in the investigator's office once a year until   show the rest ...
Final Study Results
Actual Number of Patients Enrolled In total, 955 female subjects, including 572 primary augmentation, 124 revision-augmentation,

190 primary reconstruction, and 69   show the rest ...
Actual Number of Sites Enrolled 43
Patient Followup Rate The follow-up rate at 10 years ranged from 60% to 74% across cohorts, with an   show the rest ...
Final Safety Findings The Kaplan-Meier estimated cumulative incidence rates at the subject level for the complications of any   show the rest ...
Final Effectiveness Findings For the primary augmentation cohort, the overall mean change in circumferential chest size through 10   show the rest ...
Study Strengths and Weaknesses One study strength is the 10-year prospective multi-center design to assess the long-term safety and

effectiveness   show the rest ...
Recommendations for Labeling Changes Yes, the labeling will be updated based on the post-approval study results to provide patients   show the rest ...

OSB Lead-Post-Approval PMA Cohort Study (PACS) Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
Device Retrieval report 06/14/2014 06/09/2014 On Time
one year report 06/14/2014 06/12/2014 On Time
final report 06/19/2015 06/08/2015 On Time

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