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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 Study Pending
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 & Historical Control
Analysis Type Analytical
Study Population Adult: >21


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    
18 month report 08/06/2020    
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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