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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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Enhanced Safety Surveillance Study


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P120024 / PAS002
Date Original Protocol Accepted 06/11/2015
Date Current Protocol Accepted 01/31/2020
Study Name Enhanced Safety Surveillance Study
Device Name ACTIVL ARTIFICIAL DISC
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 ESS is an unmasked, uncontrolled surveillance system of the activL for 10 years following PMA approval. Data will be collected through surgeon surveys, reporting of adverse events, and Medical Device Reports (MDRs) that may result from complaints received at Aesculap or may be filed with FDAs adverse event reporting database (Manufacturers and User Facility Device Experience, MAUDE) by a hospital or surgeon, and literature review.
Study Population Surgeons that use the device will be asked about their experience when treating patients with the activL device.
Sample Size N/A
Key Study Endpoints Information related to outcomes, subsequent surgical interventions (SSIs), additional pain management procedures, device ease of use, device satisfaction, device malfunction, device removal, and/or other serious device-related adverse events.
Explant analysis (will be reported separately)
Supporting documentation for all complaints and MDRs reported for the activL implants and instruments
Follow-up Visits and Length of Follow-up There is no patient follow-up. The surveillance system survey will be conducted annually for 10 years .


Enhanced Safety Surveillance Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/10/2015 12/10/2015 On Time
one year report 06/10/2016 06/09/2016 On Time
18 month report 12/09/2016 12/09/2016 On Time
two year report 07/09/2017 07/10/2017 Overdue/Received
three year report 06/10/2018 06/08/2018 On Time
four year report 07/24/2019 07/23/2019 On Time
five year report 11/07/2020 11/06/2020 On Time
6 year report 08/23/2021 08/23/2021 On Time
7 year report 08/08/2022 07/18/2022 On Time
8 year report 06/11/2023    


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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