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

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OSB Lead-Longterm PAS

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Study Status Completed
Application Number P890003 S119/ PAS001
Date Current Protocol Accepted 05/13/2008
Study Name OSB Lead-Longterm PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a 5-year, prospective, non-randomized, multi-center parallel study of implanted nEw3 (Adapta /Sensia/Versa) devices using a historical comparison group. Subjects will be compared against the U.S. market released Adapta /Sensia/Versa IPGs historical control group consisting of Medtronic registered devices as reported in the Medtronic Cardiac Rhythm Disease Management Product Performance Report.
Study Population Description Study Population: All enrolled subjects have been implanted with a nEw3 device. Indication: The indications include: 1) rate adaptive pacing in patients who may benefit from increased pacing rates

concurrent with increases in activity, 2) accepted patient conditions warranting chronic cardiac pacing, 3) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders, 4) the Medtronic AT500 system is also indicated for dual chamber and atrial tracking

modes in patients who may benefit from maintenance of AV synchrony.
Sample Size At least 222 patients to ensure that at least 200 subjects are followed for 5 years, it is estimated that approximately 336 subjects will need to be enrolled, 72 sites
Data Collection Medtronic CRDM considers a device as having malfunctioned whenever the analysis shows that any parameter was outside the performance limits established by Medtronic while implanted and in service. To be considered a malfunction, the device must have been returned to Medtronic and analyzed as a confirmed device malfunction. All subjects in the SLS study with a nEw3 device will be included until the cohort for analysis is met. Any nEw3 devices returned to Medtronic through returned product and found to have malfunctioned within 6 months after implant will also be included in the analysis. Devices damaged after explant, damaged due to failure to heed warnings or contraindications in the labeling, or damaged due to interaction with other implanted devices (including leads) are not considered device malfunctions.
Follow-up Visits and Length of Follow-up All subjects who are included in the analysis of the primary objective will continue to be followed for a total of 5 years post-implant. The follow-up schedule for this study is based on utilizing routine, scheduled office/clinic visits and unscheduled office/clinic visits prompted by symptoms or complaints. Follow-up office/clinic visits post-implant are suggested to be at least annually for subjects with an IPG, and a minimum of one follow-up visit every 24 months.
Interim or Final Data Summary
Interim Safety Information There were 18 deaths reported which represents 2.4% of the subjects enrolled. No deaths were deemed as system related. Two deaths were reported with unknown causes. To be considered a malfunction, the device must have been returned to Medtronic for analysis. Currently, 7 of 11 failure devices were returned. Six of the returned devices found "no anomolies" and one device revealed misshapen multi beam connectors after microscopic visual analysis of the atrial connector block.
Actual Number of Patients Enrolled 2927
Actual Number of Sites Enrolled 132
Patient Follow-up Rate 75.23%
Final Safety Findings The 5-year device survival probability was 100.0%, with 95% CI (99.7%, 100.0%).
Final Effect Findings N/A
Study Strengths & Weaknesses 1) large sample size of 2927 subjects

2) long-term follow-up for 5 years

Weakness: 1) study deviation rate of 12.16% per visit

Recommendations for Labeling Changes No

OSB Lead-Longterm PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month Report 11/13/2008 11/13/2008 On Time
1 year report 05/13/2009 05/13/2009 On Time
18 month report 11/11/2009 11/13/2009 Overdue/Received
2 year report 05/13/2010 05/13/2010 On Time
primary analysis report 03/30/2011 03/30/2011  
3 year report 05/13/2011 05/13/2011 On Time
4 year report 05/12/2012 05/08/2012 On Time
5 year report 05/12/2013 05/09/2013 On Time
6 year report 05/12/2014 05/13/2014 Overdue/Received
7 year report 05/12/2015 05/13/2015 Overdue/Received
Final Report 05/11/2016 01/08/2016 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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