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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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Study Status Completed
Application Number P980022 S012/ PAS001
Date Current Protocol Accepted 12/27/2006
Study Name PXX/GS041/A
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a randomized controlled trial, in which one arm receives the device with human albumin serum sensor and the other arm receives the device with bovine albumin serum sensor.
Study Population Description Study Population: Patients aged 18 to 65 years, previously diagnosed with type 1 diabetes, and currently using an insulin pump or multiple daily injections. Indication: The device is used in patients with diabetes as a continuous glucose monitoring system in conjunction with a standard home blood glucose meter.
Sample Size 78 patients, 4 sites
Data Collection The clinical endpoints to be measured consist of capillary blood glucose concentration as measured by the One-Touch Ultra Meter, and glucose values calculated from sensor signals measured by the Guardian RT System. The safety endpoints consist of device effects and frequency of device complications associated with the Guardian RT System. Data collection consited of a download the continious glucose monitoring system and glucose meter data as well as interview the patient at office visits.
Follow-up Visits and Length of Follow-up After enrollment, subjects will be followed by phone calls on day 3, day 18, and day 21. On day 30s the end of study, subjects will return all study supplies to the site, and data will be uploaded to a computer for analysis and review.
Interim or Final Data Summary
Interim Safety Information Study completed, see final results.
Actual Number of Patients Enrolled 78
Actual Number of Sites Enrolled 4
Patient Follow-up Rate 80%
Final Safety Findings A total of five adverse events were reported across 4 subjects during the study. All reported complete recovery. Two of the subjects experienced skin disorders (rash and/or itching); one subject experienced a hypoglycemic event, which was considered severe (the subject showed complete recovery after treatment with concomitant medications); and one subject experienced a syncopal episode (subject passed out after inserting a sensor) and withdrew from the study.
Study Strengths & Weaknesses Strength: The study was designed as a randomized controlled trial.
Recommendations for Labeling Changes There were no recomendations made for labeling changes.

PXX/GS041/A Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 06/27/2007 06/19/2007 On Time
1year report 12/30/2007 12/20/2007 On Time
18 month report 06/29/2008 06/17/2008 On Time
Final Report 10/01/2008 09/30/2008 On Time

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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