• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

OSB Lead-QuickFlex u Model 1258T LV lead


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Application Number P030054 S130/ PAS001
Current Plan Approved 05/10/2010
Study Name OSB Lead-QuickFlex u Model 1258T LV lead
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is designed to characterize the chronic performance of the St. Jude Medical QuickFlex® ì Model 1258T LV Lead.
Study Population Description Study Population: Patients with an approved indication, as per cardiovascular society guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s). Indication: The device is indicated for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
Sample Size 1884 patients, 80 sites
Data Collection Complication free survival rate at 5 years for complications related to the RV lead or SJ4 connector is greater than 92.5%. The following complications will be included in this analysis: Cardiac perforation, Lead dislodgement that occurred greater than 30 days after implant, Lead insulation damage, Lead fracture, Lead/Port damage, Abnormal RV lead performance (abnormal lead defibrillation impedance, abnormal lead pacing impedance, elevated pacing thresholds, loss of capture, loss of defibrillation output, loss of sensing, oversensing, undersensing), Other unexpected complications that are considered related to the RV lead or SJ4 connector
Follow-up Visits and Length of Follow-up Patients will be followed every six months for 5 years
Final Study Results
Interim Safety Information There were 34 device-related complications in 22 patients in the PAS study. Of the 34 complications, 13 have been classified as right ventricular lead or SJ4 connector related complications.


OSB Lead-QuickFlex u Model 1258T LV lead Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/08/2010 11/12/2010 Overdue/Received
one year report 05/10/2011 05/10/2011 On Time
18 month report 11/08/2011 11/09/2011 Overdue/Received
2 year report 05/09/2012 05/10/2012 Overdue/Received
30 month report 11/09/2012 11/13/2012 On Time
3 year report 05/09/2013 05/14/2013 Overdue/Received
42 month report 11/09/2013 11/12/2013 Overdue/Received
4 year report 05/09/2014 05/07/2014 On Time
54 month report 11/09/2014 11/24/2014 Overdue/Received
5 year report 05/09/2015 05/06/2015 On Time
66 month report 11/10/2015 11/10/2015 On Time
6 year report 05/09/2016 05/03/2016 On Time
78 month report 11/10/2016 11/10/2016 On Time


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

Related Links

-
-