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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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Histological and Retrieval Analysis PAS


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General
Study Status Study Pending
Application Number P160050 / PAS002
Study Name Histological and Retrieval Analysis PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this post-approval evaluation is to investigate potential underlying mechanisms that may contribute to endplate lesion (EPL) initiation and/or growth through retrieval analysis and histological analysis of retrieved implants and/or peri-prosthetic tissue. This study is also intended to evaluate causes of device failure (fracture, migration, dissociation and wear particulate). Analysis of tissue and devices/material from retrieved (explanted) Barricaid® ACDs that were originally implanted following discectomy in real-world (i.e., commercial, not clinical study) experience.
Study Population Description All patients implanted with a Barricaid® ACD in the United States.
Sample Size This evaluation is not powered to demonstrate statistical conclusions, but rather to gather data for subsequent analysis and surveillance.
Data Collection Histological analysis of tissue and explant material will be assessed per ASTM F561-13.
Follow-up Visits and Length of Follow-up This evaluation shall remain in place for 5 years


Histological and Retrieval Analysis PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/09/2019   Overdue
one year report 02/08/2020    
18 month report 08/08/2020    
two year report 02/07/2021    
three year report 02/07/2022    
four year report 02/07/2023    


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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