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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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OSB Lead-Extended f/u of premarket cohort

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Study Status Progress Adequate
Application Number P110002 / PAS001
Current Plan Approved 05/27/2014
Study Name OSB Lead-Extended f/u of premarket cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective of the study is to evaluate the overall long-term success rate (see primary end-points for the definitions) of the investigational device as compared to the control in subjects enrolled in the pivotal IDE study of the Mobi-C (1-levels) device (IDE Number G050212).

Design-Prospective Cohort (extended follow-up of IDE patients)

Study Population Description All eligible Mobi-C patients treated at one level. All eligible fusion patients treated at one level under the LDR-001 Pivotal Study (IDE G050212)
Sample Size 245 subjects are still enrolled in the study (at the time of the Primary Endpoint 24 month analysis) and eligible for long term follow-up in the post-approval study. This includes 155 randomized investigational subjects, 75 randomized control subjects, and 15 non-randomized training case (investigational) subjects.
Data Collection The primary endpoint of the study is individual patient success which is defined using the two measures of composite study success. 1. When assessing the composite endpoint, all components need to be successful for the endpoint to be considered a success. However, only 1 component needs to be a failure for the endpoint to be considered a failure.

2. Note: the data will be also analyzed for the primary

outcome based on the 2nd definition for the success. See approval condition #1 and page 18 for the current submission.

Follow-up Visits and Length of Follow-up 7-years

At 7th year

OSB Lead-Extended f/u of premarket cohort Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 02/05/2014 02/04/2014 On Time
one year report 08/07/2014 08/07/2014 On Time
two year report 08/07/2015 08/10/2015 Overdue/Received
Final Report 05/27/2016 05/31/2016 Overdue/Received

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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