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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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ODE Lead-Device Failure and Complaint Analysis


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General
Study Status Progress Adequate
Application Number P090029 S006/ PAS001
Date Current Protocol Accepted  
Study Name ODE Lead-Device Failure and Complaint Analysis
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is intended to study the long term performance of the Prestige LP Cervical Disc. These observations include all AE, including device related AE, HO, reoperations/revisions/removals and metal ion related outcomes due to the new material. This incorporates 10 year follow-up for IDE cohort as well as commercial use.
Study Population Description All patients with Prestige LP Cervical Disc within the study period, 10 years from PAS protocol approval.
Data Collection Effectiveness - N/A

Safety – AE, Serious AE, Explant Analysis, Metal Ion Analysis

Follow-up Visits and Length of Follow-up 10 years (120 months) following approval of S003 (for two level patients)


ODE Lead-Device Failure and Complaint Analysis Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 07/24/2017 07/21/2017 On Time
two year report 07/24/2018    
three year report 07/24/2019    
four year report 07/24/2020    
five year report 07/24/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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