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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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OSB Lead-Enhanced Safety Surveillance Study


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General
Study Status Progress Adequate
Application Number P120024 / PAS002
Date Current Protocol Accepted 04/26/2017
Study Name OSB Lead-Enhanced Safety Surveillance Study
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 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 FDA¿s adverse event reporting database (Manufacturers and User Facility Device Experience, MAUDE) by a hospital or surgeon, and literature review.
Study Population Description Surgeons that use the device will be asked about their experience when treating patients with the activL device.
Sample Size N/A
Data Collection 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 .


OSB Lead-Enhanced Safety Surveillance Study Schedule

Report 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    
four year report 06/10/2019    
five year report 06/09/2020    


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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