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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 P020056 / PAS007
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 Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Subjects comprising the Re-Op Phase of the BIFS (Large PAS) will be followed for data collection during reoperation events.
Study Population Description The NBIR arm consists of subjects implanted with round responsive devices or saline devices who were originally enrolled in the BIFS study but were not selected to remain in the smaller 10-year follow-up cohort study (BIFS arm).
Sample Size 37,390 subjects with Natrelle silicone gel-filled breast implants and 14,995 subjects with saline-filled breast implants.
Data Collection Implant removal and reoperation rates; Reasons for reoperation.
Follow-up Visits and Length of Follow-up The follow-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 07/16/2015 On Time
one year report 01/16/2016 01/15/2016 On Time
18 month report 07/16/2016 07/15/2016 On Time
two year report 01/16/2017 01/17/2017 Overdue/Received
three year report 01/16/2018    
four year report 01/16/2019    


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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