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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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OSB Lead-Re-Op Phase


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General
Study Status Progress Adequate
Application Number P030053 / PAS009
Date Current Protocol Accepted 01/16/2015
Study Name OSB Lead-Re-Op Phase
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 Design Description The Re Op Phase will collect data when a Large PAS participant with MemoryGel breast implants requires a secondary procedure/reoperation
Study Population Description Women with MemoryGel breast implants who were enrolled in the Large PAS.
Sample Size 41,900
Data Collection Implant removal and reoperation rates; Reasons for reoperation.
Follow-up Visits and Length of Follow-up The follow쳌]up data will be collected when the participant requires a secondary procedure/reoperation.


OSB Lead-Re-Op Phase Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/16/2015 07/09/2015 On Time
one year report 01/16/2016 01/15/2016 On Time
18 month report 07/16/2016 07/14/2016 On Time
two year report 01/16/2017 01/11/2017 On Time
three year report 01/16/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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