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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-Retrieval Analysis

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Application Number P110002 / PAS003
Current Plan Approved 07/15/2014
Study Name OSB Lead-Retrieval Analysis
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source Other Data Source
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 Retrieval Analysis: to asses device failure modes or adverse event profile with a possible relationship to the clinical and demographic characteristic (if the data permits) for one and two level patients with the device.

Design-case series (if clinical data is available) premarket cohorts, new enrollment or both.

Study Population Description All patients with Mobi-C Cervical Disc whose device has been

removed and subjected to retrieval analysis

Sample Size NA (bench study)
Data Collection Implant Failure Modes

Adverse Event Profile

Possible relationship of the mechanical wear to the clinical characteristics of the patient (if data is available)

Follow-up Visits and Length of Follow-up 10 years f/u

OSB Lead-Retrieval Analysis Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/08/2014 08/08/2014 On Time
one year report 08/15/2015 08/17/2015 Overdue/Received
two year report 08/15/2016 08/15/2016 On Time
three year report 08/15/2017    

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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