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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-Attain Ability Straight Model 4396

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Application Number P080006 S004/ PAS001
Current Plan Approved 06/29/2015
Study Name OSB Lead-Attain Ability Straight Model 4396
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective Cohort Study
Study Population Description Inclusion Criteria

Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

Subject is implanted with the Model 4396 LV lead connected and used for a pacing or sensing.

Subject within 30 days of implant

Exclusion Criteria

Subject who is, or will be inaccessible for follow-up at a site

Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)

Complete implant and follow-up data, including any product-related events at implant through the time of enrollment are unavailable

Sample Size This study will consist of 1,016 patients implanted with Model 4396 lead enrolled from approximately 150 centers globally. The minimum Model 4396 enrollment of 1,016 leads results in approximately 600 leads followed for 5-years.
Data Collection The primary objective of the PAS is to demonstrate that the Model 4396 lead-related complication-free rate is greater than 92.5% at five years post-implant.
Follow-up Visits and Length of Follow-up Subjects in the PAS will be followed for a minimum of 5 years from their implant date.

Study follow-up visit schedules are based on a rolling visit window with the visit frequency: The required visit window is 210 days in length or approximately every 6 months from implant.

OSB Lead-Attain Ability Straight Model 4396 Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/30/2011 09/28/2011 On Time
one year report 03/30/2012 03/26/2012 On Time
18 month report 09/29/2012 09/28/2012 On Time
two year report 03/30/2013 03/28/2013 On Time
30 month report 09/29/2013 09/27/2013 On Time
three year report 03/30/2014 03/25/2014 On Time
42 month report 09/29/2014 09/16/2014 On Time
four year report 03/30/2015 03/20/2015 On Time
54 month report 09/29/2015 09/22/2015 On Time
five year report 03/30/2016 03/31/2016 Overdue/Received
66 month report 09/29/2016 09/27/2016 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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