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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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Extended f/u of the 2-Level Simplify


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General
Study Status Study Pending
Application Number P200022 S003/ PAS001
Date Current Protocol Accepted  
Study Name Extended f/u of the 2-Level Simplify
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: To evaluate the 5 year long-term safety and effectiveness of the two-level Simplify Cervical Artificial Disc in subjects with cervical

radiculopathy with or without neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces

that are unresponsive to conservative management.

Design: A continuation of the prospective, multi-center, historically controlled IDE study population to evaluate the long-term safety and

effectiveness of the Simplify Cervical Artificial Disc.
Study Population Description Investigational Device: Simplify Cervical Artificial Disc

Historical Control: Anterior Cervical Discectomy and Fusion (ACDF)
Sample Size 170 Simplify Cervical Artificial Disc IDE subjects and 151 historical ACDF control subjects are eligible for the PAS study
Data Collection Safety Endpoints:

Collection and evaluation of all adverse events for severity and device and/or procedure-relatedness

Evaluation of device failure (device breakage, migration, or mechanical failure) as defined in Radiographic Evaluation Protocol

Subsequent surgical procedures (revision, removal, reoperation, or supplemental fixation) at the index levels

Neurologic evaluation

Dysphagia Handicap Index (DHI)

Effectiveness Endpoints:

Neck Disability Index (NDI) assessment

Radiographic evaluation

Pain assessments (neck and arm; neck, left arm and right arm)

Treatment satisfaction

SF-36 Health Survey

Gait Assessment
Follow-up Visits and Length of Follow-up 5 years


Extended f/u of the 2-Level Simplify Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/30/2021    
one year report 04/01/2022    
two year report 04/01/2023    
three year report 03/31/2024    
four year report 03/31/2025    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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