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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 Enhanced Surveillance


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General
Application Number P100012 / PAS001
Current Plan Approved 08/25/2015
Study Name OSB Lead-PCM Cervical Enhanced Surveillance
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 The study design is enhanced surveillance.
Study Population Description Skeletally mature patients for reconstruction of a degenerated cervical

disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space.

Sample Size The sample size is comprised of all patients who receive the device after its approval. All US physicians who utilize the device will be surveyed.

Data Collection Subsequent surgeries, heterotopic ossification, and other device related

adverse events

Follow-up Visits and Length of Follow-up Surgeons will be surveyed on an annual basis and for ten (10) years from the PMA approval date.



OSB Lead-PCM Cervical Enhanced Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/26/2013 04/24/2013 On Time
one year report 10/26/2013 10/25/2013 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 10/26/2015 10/23/2015 On Time
four year report 10/25/2016    
five year report 10/25/2017    


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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