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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Post-Approval PMA Cohorts Study (PACS)

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Study Status Progress Adequate
Application Number P070004 / PAS001
Date Current Protocol Accepted 05/29/2012
Study Name Post-Approval PMA Cohorts Study (PACS)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Post-approval PMA Cohorts Study (PACS) will continue to follow subjects from premarket cohorts for 10 years in order to assess the long-term clinical performance of the approved device. The PACS data are to be collected via annual physician follow-up evaluations and all patients in the study will have MRI at years 6, 8, and 10.
Study Population Description Women who received Sientra¿s silicone breast implants and were enrolled in the premarket Core Study and reconstruction cohorts of the Continued Access Study. The data obtained at baseline on each subject will be used as the control data for physical status, cancer history and status, rheumatologic history and status, medical history and status, and CTD history and status.
Sample Size A total of 1,788 subjects have been enrolled in Sientra¿s PACS at 33 sites throughout the United States.
Data Collection The safety endpoints include local complications, implant rupture, connective tissue diseases (CTDs), CTD signs and symptoms, lactation complications, cancer and suicide. Effectiveness will be assessed based on quality of life (QOL) assessments and subject satisfaction.
Follow-up Visits and Length of Follow-up 10 years


Post-Approval PMA Cohorts Study (PACS) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/07/2012 09/07/2012 On Time
one year report 03/09/2013 03/12/2013 Overdue/Received
two year report 03/09/2014 03/07/2014 On Time
three year report 03/09/2015 03/10/2015 Overdue/Received
four year report 03/08/2016 03/07/2016 On Time
five year report 03/08/2017 03/03/2017 On Time
Final Report 03/09/2018 03/08/2018 On Time

Contact Us

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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