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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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PCM Cervical Enhanced Surveillance


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General
Study Status Terminated
Application Number /
Requirement Number		 P100012 / PAS001
Date Original Protocol Accepted 10/26/2012
Date Current Protocol Accepted 08/25/2015
Study Name PCM Cervical Enhanced Surveillance
Device Name NUVASIVE PCM CERVICAL DISC 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 Objectives The study design is enhanced surveillance.
Study Population 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.
Key Study Endpoints 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.
Interim or Final Data Summary
Interim Results A total of 128 physicians were identified to survey. Of the surgeons surveyed, 8 responded. The
overall response rate was 6.25% (8/128).
Actual Number of Patients Enrolled N/A
There is no enrollment of patients. All patients who have received this device in the post-market
environment, i.e. all patients who are implanted with the device. The intended patient
population under general conditions of use in the United States and in the rest of the world.
Actual Number of Sites Enrolled N/A
Annual surgeon survey: active collection of surgeon feedback annually to elicit information
related to heterotopic ossification, device malfunction, device removal, or other serious devicerelated
complications.
Patient Follow-up Rate Numbers of sites, IRB approvals and study participants are not available, since this ESS does not
include enrollment of sites/patients. There is no enrollment of patients.
Study Strengths & Weaknesses N/A


PCM Cervical Enhanced Surveillance Reporting Schedule

Reporting 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 10/26/2016 Overdue/Received
five year report 10/25/2017 10/25/2017 On Time
six year report 10/25/2018 12/07/2018 Overdue/Received
seven year report 10/25/2019 10/25/2019 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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