f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Lap-Band Long Term


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General
Study Status Redesigned/Replaced Study
Application Number /
Requirement Number		 P000008 / PAS001
Date Original Protocol Accepted 06/05/2001
Date Current Protocol Accepted 06/05/2001
Study Name Lap-Band Long Term
Device Name LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective cohort, which involved continued follow-up of subjects from the premarket studies, from several different sites. Both prospective and retrospective collection of data was allowed and encouraged.
Study Population Study Population: Patients included in the pre-market study. Indication: The LAGB is intended for use in weight reduction for morbidly obese adult patients with a Body Mass Index (BMI) of at least 40 kg/m2, a BMI of at least 35 kg/m2 with at least one co-morbid condition, or those who are 100 lbs. or more above their ideal body weight and who have failed at more conservative weight reducing alternatives.
Sample Size 300 patients, 15 sites
Key Study Endpoints Safety endpoints included percent of excess weight loss, adverse events, and explantation of the device.
Follow-up Visits and Length of Follow-up Patients who had completed three years of follow-up in the premarket studies were to be followed for an additional two years.


Lap-Band Long Term Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
PAS status report 10/15/2007 10/15/2007 On Time
Yearly Report 07/05/2008 07/31/2008 Overdue/Received
Annual report 08/28/2009 08/28/2009 On Time
PAS Annual Report 08/28/2010 09/03/2010 Overdue/Received
report 07/06/2011 07/06/2011 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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