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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Device failure Study


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General
Study Status Other
Application Number /
Requirement Number		 P020056 / PAS005
Date Original Protocol Accepted 11/17/2006
Date Current Protocol Accepted 11/17/2006
Study Name Device failure Study
Device Name NATRELLE SILICONE-FILLED BREAST IMPLANTS
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive


Device failure Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 year report 11/16/2008 10/27/2008 On Time
3 year report 11/16/2009 11/13/2009 On Time
4 year report 11/16/2010 11/10/2010 On Time
5 year report 11/16/2011 11/09/2011 On Time
6 year report 11/15/2012 11/14/2012 On Time
7 year report 11/15/2013 11/13/2013 On Time
Change in Report and Study Status 09/05/2014 09/05/2014 On Time

* Sponsor is reporting failure study data in the regular PMA Annual Report.



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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