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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Enhanced Surveillance System

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Application Number P110009 / PAS002
Current Plan Approved 05/19/2014
Study Name OSB Lead-Enhanced Surveillance System
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description A 10-year Enhanced Surveillance Study (ESS) of the Mobi-C®

Cervical Disc Prosthesis to fully characterize adverse events

and complaints when the device is used in the intended patient population under general conditions of use in the United States and in the rest of the world.

The objective is to collect, analyze, and submit all adverse event data.

Study Population Description All patients who are implanted with the device

The data on AEs will be collected by the company and reported to the FDA:

1. Through literature search (every 6 months for first 2 years and then annually thereafter)

2. AEs reported through company website

3. MDR reports

4. Annual survey of all USA physicians who were trained with the device

Sample Size N/A
Data Collection All adverse Events will be reported including HO, neurological

complications, subsequent surgeries and etc. The data will be categorized based on severity, and device and MDR relevancy

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

OSB Lead-Enhanced Surveillance System Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 02/21/2014 02/21/2014 On Time
one year report 08/23/2014 08/21/2014 On Time
18 month report 02/21/2015 02/23/2015 Overdue/Received
two year report 08/23/2015 08/20/2015 On Time
three year report 08/23/2016 08/22/2016 On Time
four year report 08/23/2017    
five year report 08/23/2018    
six year report 08/23/2019    
seven year report 08/23/2020    
eight year report 08/23/2021    
nine year report 08/23/2022    
ten year report 08/23/2023    

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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