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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Focus Group


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General
Study Status Completed
Application Number /
Requirement Number		 P020056 / PAS003
Date Original Protocol Accepted 11/17/2006
Date Current Protocol Accepted 11/17/2006
Study Name Focus Group
Device Name NATRELLE SILICONE-FILLED BREAST IMPLANTS
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Interim or Final Data Summary
Actual Number of Patients Enrolled There were 29 augmentation participants and 23 reconstruction participants.
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A, There was no follow-up of focus group participants.
Final Safety Findings N/A, There are no safety findings.
Study Strengths & Weaknesses The strength of the study was that the focus groups included augmentation and reconstruction patients. The weakness of the study was that the participants many not be representative of all breast implant patients.
Recommendations for Labeling Changes Changes were made to the Patient Planner based on the recommendatin of the focus groups. These changes included changing the order of text in the planner and making the planner available on-line.


Focus Group Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Focus Group Study Final Report 11/17/2007 11/16/2007 On Time


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

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