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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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Post-Approval Study


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General
Study Status Progress Adequate
Application Number P160039 / PAS001
Date Current Protocol Accepted  
Study Name Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multicenter, single arm cohort study to evaluate long-term safety, long-term effectiveness, and survival rate in the continued follow-up of the premarket cohort for the remede System Pivotal Trial.
Study Population Description Subjects who were previously implanted with the remede System and participated in the remede System Pivotal Trial
Sample Size Up to 94 subjects are available for the extended follow-up
Data Collection 1. Evaluate the survival rate

2. Evaluate long-term three and five-year device-related SAEs

3. Evaluate long-term three and five-year therapy-related SAEs

4. Evaluate the AHI, CAI and obstructive apnea index (OAI)

5. Evaluate the change in quality of life from Baseline

Follow-up Visits and Length of Follow-up Follow-up is planned for five years from the date of implant. Since all subjects have already completed 24 months of follow-up, total study duration is estimated to be three years.

30, 36, 42, 48, 54, 60 months follow-up assessments planned



Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/06/2018 04/06/2018 On Time
one year report 10/06/2018 10/05/2018 On Time
18 month report 04/06/2019 04/05/2019 On Time
two year report 10/06/2019    
three year report 10/05/2020    


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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