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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Longterm


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General
Study Status Completed
Application Number /
Requirement Number		 P030054 S019/ PAS001
Date Original Protocol Accepted 03/14/2006
Date Current Protocol Accepted 03/14/2006
Study Name Longterm
Device Name EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE
General Study Protocol Parameters
Study Design Prospective & Retrospective 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


Longterm Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year reports 03/14/2007 01/23/2007 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

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