f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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 Cohort Study (PACS)


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General
Study Status Completed
Application Number /
Requirement Number		 P120011 / PAS001
Date Original Protocol Accepted 11/14/2014
Date Current Protocol Accepted 11/14/2014
Study Name Post-Approval PMA Cohort Study (PACS)
Device Name Puregraft Serene Breast Implant
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study will continue to follow subjects from the premarket cohorts for 10 years. The data are to be collected via annual physician follow-up evaluations
Study Population Women aged 18 or over who are undergoing primary breast augmentation or replacement of existing augmentation implants
Sample Size 502 subjects enrolled at 35 study sites
Key Study Endpoints Safety endpoints: The incidence and timing of all adverse events that are collected throughout the study. Additionally, several distinct adverse events, including peri-prosthetic infection, seroma, capsule contracture (Baker class II-IV), explant, spontaneous failure of the inner shell, spontaneous failure of the outer shell and spontaneous deflation will be summarized separately
Effectiveness endpoints: Increase in breast size; Patient satisfaction; Investigator satisfaction
Follow-up Visits and Length of Follow-up 10 years
All subjects will be followed annually through 10 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 503
Actual Number of Sites Enrolled 32
Patient Follow-up Rate The follow-up rate was 92.7% for primary augmentation cohort and 96.6% for revision augmentation cohort at 10 years.
Final Safety Findings pending final labeling review
Final Effect Findings pending final labeling review
Study Strengths & Weaknesses pending final labeling review
Recommendations for Labeling Changes Yes, labeling to be updated with 10 year data.


Post-Approval PMA Cohort Study (PACS) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 11/14/2015 11/10/2015 On Time
2 year report 11/13/2016 11/14/2016 Overdue/Received
3 year report 11/13/2017 11/13/2017 On Time
4 year report 11/13/2018 11/13/2018 On Time
5 year report 11/13/2019 11/13/2019 On Time
final report 05/14/2021 05/21/2021 Overdue/Received


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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