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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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New Enrollment Study

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Study Status Progress Adequate
Application Number P130008 / PAS002
Date Current Protocol Accepted 09/11/2017
Study Name 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 New enrollment multi-center, prospective, single arm cohort study.
Study Population Description Device group: Patients implanted with the Inspire II Upper

Airway Stimulator

Comparator group: None

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

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 04/26/2018 On Time
five year report 04/29/2019 04/30/2019 Overdue/Received
six year report 04/28/2020    
seven year report 04/28/2021    
Final Report 02/29/2024    

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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