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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-New Enrollment Study

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Study Status Progress Inadequate
Application Number P130008 / PAS002
Current Plan Approved 06/01/2016
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To collect additional long term safety, training performance and effectiveness data in a postmarket setting. A multi-center, prospective, single arm study, new enrollment.
Study Population Description Patients will be screened for inclusion/exclusion criteria.

Eligible subjects will be implanted and followed for five years.

Sample Size A total of 127 subjects will be implanted at a minimum of 10 and a maximum of 20 qualified sites in the United States.

Data Collection Safety Endpoints

Evaluate long-term device-related serious adverse events.

Evaluate therapy-specific adverse events (stimulation discomfort, tongue abrasions weakness and deviation) at

12 months.

Evaluate long-term therapy-related adverse events.

Training Measures

Physician training measures of post-operative safety outcome.

Effectiveness Endpoints

Quality of life measures using Epworth Sleepiness Scale (ESS) at 12 months

Quality of life measure using Functional Outcomes of Sleep questionnaire at 12 months

Therapy efficacy measured by ESS and FOSQ annually up to 5 years.

Therapy efficacy measured by AHI, ODI from a single night in-sleep study at 3 years
Follow-up Visits and Length of Follow-up 5 years post-implant

A single night in-lab Polysomnography (PSG) sleep study will be conducted at baseline, and a sleep study (a PSG or HST at the discretion of the investigator) at the 1st and 3rd year follow ups. Two nights home sleep testing (HST) will be conducted at the 2nd, 4th, and 5th year follow ups.

OSB Lead-New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/29/2014 10/30/2014 Overdue/Received
one year report 04/30/2015 04/29/2015 On Time
18 month report 10/29/2015 11/02/2015 Overdue/Received
two year report 04/29/2016 04/29/2016 On Time
30 month report 11/01/2016 11/01/2016 On Time
three year report 04/29/2017 05/01/2017 Overdue/Received
four year report 04/29/2018    
five year report 04/29/2019    
six year report 04/28/2020    
seven year report 04/28/2021    
Final Report 09/28/2021    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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