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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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Protego DF4 Post Approval Registry


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General
Study Status Progress Adequate
Application Number P980023 S057/ PAS001
Date Current Protocol Accepted 04/15/2019
Study Name Protego DF4 Post Approval Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Admin Database
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Detailed Study Protocol Parameters
Study Design Description This study is designed to gather safety data on BIOTRONIK’s lead using active monitoring of Medicare fee-for-service (FFS) claims data. The design is a prospective, single-arm, non-randomized, observational cohort study utilizing real world data.
Study Population Description Patients who are implanted with the lead and are in the beneficiary match population for the claims data are included in the patient population.
Sample Size 750 minimum evaluable sample required to demonstrate superiority to a complication-free rate of 92.5%.
Data Collection The purpose of primary endpoint 1 is to evaluate the overall incidence of complications attributable to the lead through 5 years post-implant.
Follow-up Visits and Length of Follow-up 5 year's post-implant


Protego DF4 Post Approval Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/01/2015 12/15/2014 On Time
one year report 07/03/2015 06/26/2015 On Time
18 month report 01/01/2016 12/31/2015 On Time
two year report 07/02/2016 06/28/2016 On Time
three year report 07/02/2017 06/28/2017 On Time
four year report 07/02/2018 07/02/2018 On Time
abbreviated report 07/01/2019 07/01/2019  
five year report 10/15/2019   On Time
six year report 10/15/2020    
seven year report 10/15/2021    
eight year report 10/15/2022    
nine year report 10/15/2023    
Final report 10/02/2024    


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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