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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Thoratec TLC-ii portable


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General
Study Status Other
Application Number /
Requirement Number		 P870072 S037/ PAS001
Date Original Protocol Accepted 11/14/2007
Date Current Protocol Accepted 11/14/2007
Study Name Thoratec TLC-ii portable
Device Name THORATEC TLC-II PORTABLE VAD DRIVER
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study requires the sponsor submit data on driver failure on a quaterly basis.
Study Population N/A
Sample Size N/A
Key Study Endpoints Reporting includes: 1) the number of adverse events reported that are potentially related to driver malfunction or failure, along with a narrative description of each case and the percent brush remaining (if known); and 2) the percent brush remaining for all motors you replaced or serviced, along with duration of use prior to servicing.
Follow-up Visits and Length of Follow-up N/A


Thoratec TLC-ii portable Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Driver Failure Report 03/05/2008 03/03/2008 On Time
Status Update Driver Failure Reporting 09/05/2008 09/05/2008 On Time
Annual PAS Report 11/14/2008 12/02/2008 Overdue/Received


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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