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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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M6-C Artificial Cervical Disc-Extended Follow-up


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General
Study Status Progress Adequate
Application Number P170036 / PAS001
Date Current Protocol Accepted  
Study Name M6-C Artificial Cervical Disc-Extended Follow-up
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: To evaluate the 10-year long-term safety and effectiveness of the M6-C™ Artificial Cervical Disc in subjects with symptomatic cervical radiculopathy with or without cord compression.



Design: A continuation of the Prospective, multi-center, concurrently controlled IDE Study population to evaluate the long-term safety and effectiveness of the M6-C™ Artificial Cervical Disc.

Study Population Description Treatment group: M6-C™ Artificial Cervical Disc

Control group: Anterior Cervical Discectomy and Fusion (ACDF)

Sample Size Expected 122 M6-C™ IDE subjects and 53 ACDF control subjects

Data Collection Safety Endpoints:

The evaluation of all adverse events including device related, device procedure related, and additional serious adverse events

Explant and histological analysis

Subsequent surgical interventions

Neurological function



Effectiveness Endpoints:

Neck Disability Index (NDI)

Neck and arm pain - Visual Analog Scale (VAS)

Patient Satisfaction

Quantitative and qualitative radiographic assessments. In addition to endpoints studied for the PMA, these assessments will be used to evaluate range of motion and adjacent segment degeneration.



Follow-up Visits and Length of Follow-up 10 years


M6-C Artificial Cervical Disc-Extended Follow-up Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/07/2019 07/30/2019  
one year report 02/06/2020 01/31/2020 On Time
18 month report 08/06/2020 07/07/2020 On Time
two year report 02/05/2021    
three year report 02/05/2022    


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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