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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-All Comers Registry


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General
Application Number H100004 / PAS001
Current Plan Approved 07/27/2012
Study Name OSB Lead-All Comers Registry
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description The study will be an all-comers prospective registry
Study Population Description Patients implanted with the EXCOR Pediatric VAD per indications for use
Sample Size 49 patients (39 for complete follow-up), 10 to 50 sites
Data Collection Primary safety: serious adverse event rates of

Major Bleeding

Cardiac Arrhythmias

Pericardial Fluid Collection (with and without Tamponade)

Hemolysis

Hepatic Dysfunction

Hypertension

Major infection

Myocardial Infarction

Neurological Dysfunction

Psychiatric Episode

Renal Dysfunction

Respiratory Failure

Right Heart Failure

Arterial Non-CNS Thromboembolism

Venous Thromboembolism

Wound Dehiscence

Other



Primary effectiveness: transplant, recovery of left ventricular function or death

Follow-up Visits and Length of Follow-up 24 months post-implant

Pre-implant, Discharge, Post-implant at 3 & 6 weeks, 3, 6, 12, and 24 months



OSB Lead-All Comers Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/27/2013 02/11/2013 Overdue/Received
one year report 07/27/2013 07/31/2013 Overdue/Received
18 month report 02/26/2014 02/26/2014 On Time
two year report 07/27/2014 07/28/2014 Overdue/Received
interim report (3 year) 07/27/2015 04/30/2015 On Time
4 year report 07/27/2016 07/11/2016 On Time
final report 01/27/2017    


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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