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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Thoratec TLC-ii portable


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General
Application Number P870072 S037/ PAS001
Current Plan Approved 11/14/2007
Study Name OSB Lead-Thoratec TLC-ii portable
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 Design Description This study requires the sponsor submit data on driver failure on a quaterly basis.
Study Population Description N/A
Sample Size N/A
Data Collection 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
Final Study Results
Interim Safety Information N/A, This is a bench testing study.


OSB Lead-Thoratec TLC-ii portable Schedule

Report 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

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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