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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-Post-Approval PMA Cohort Study (PACS)


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General
Study Status Progress Adequate
Application Number P120011 / PAS001
Date Current Protocol Accepted 11/14/2014
Study Name OSB Lead-Post-Approval PMA Cohort Study (PACS)
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 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 Description 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
Data Collection 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


OSB Lead-Post-Approval PMA Cohort Study (PACS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 11/14/2015 11/10/2015 On Time
two year report 11/13/2016 11/14/2016 Overdue/Received
three year report 11/13/2017   Overdue
four year report 11/13/2018    
five year report 11/13/2019    
Final report 09/12/2020    


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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