Post-Approval Studies (PAS) Database

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)

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
Clinical Trial Number(s)	NCT00858052
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

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background