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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-PCM Cervical Long Term

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Application Number P100012 / PAS002
Current Plan Approved 02/06/2013
Study Name OSB Lead-PCM Cervical Long Term
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multi-center randomized clinical trial
Study Population Description The study population is comprised of patients who received the device during the IDE or controls that underwent ACDF during the IDE.
Sample Size The sample size is comprised of 142 PCM cervical disc patients and

110 controls that underwent ACDF.

Data Collection The primary endpoint will be individual subject success at the 7 year visit. ┬┐Success┬┐ is defined as:

Improvement of at least 20% on the Neck Disability Index (NDI) at 7 years compared to baseline;

No device failures (at the index level) requiring revision, re-operation, removal, or supplemental fixation;

No major complications such as vascular or neurological injury;

Radiographic success

Secondary endpoints include neurological assessment, Neck and Arm Pain Visual Analog Scale, and Short-Form-36 Health Survey Questionnaire.

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

Patients will undergo follow-up assessments at 5, 6, and 7 post-operative years..

OSB Lead-PCM Cervical Long Term Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/26/2013 04/24/2013 On Time
one year report 11/25/2013 11/22/2013 On Time
18 month report 04/26/2014 04/24/2014 On Time
two year report 10/26/2014 10/21/2014 On Time
three year report-FINAL 10/24/2015 10/22/2015 On Time

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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