f Post-Approval Studies (PAS) Database
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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 Ongoing
Application Number /
Requirement Number		 P200022 S003/ PAS001
Date Original Protocol Accepted 05/28/2021
Date Current Protocol Accepted  
Study Name Extended f/u of the 2-Level Simplify
Device Name Simplify Cervical Artificial Disc
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 Objectives 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 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
Key Study Endpoints 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 Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 04/01/2022 04/08/2022 Overdue/Received
2 year report 04/01/2023 04/03/2023 Overdue/Received
final report 04/01/2024 04/01/2024 On Time


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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