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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) 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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Study Status Progress Adequate
Application Number P100012 / PAS001
Date Current Protocol Accepted 08/25/2015
Study Name 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.

Interim or Final Data Summary
Interim Safety Information 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

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 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 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
eight year report 10/26/2020    
nine year report 10/25/2021    
final report 11/25/2022    

Contact Us

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

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