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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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ODE Lead-Micra Rate Resp Conf Study


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General
Study Status Progress Adequate
Application Number P150033 / PAS001
Date Current Protocol Accepted  
Study Name ODE Lead-Micra Rate Resp Conf Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description Medtronic is sponsoring the Micra System Post-Approval Study (PAS) to further confirm safety and effectiveness of the system when used as intended, in “real-world” clinical practice, following commercial release. Data will be collected from following current premarket patients and new patients.
Study Population Description Patients indicated for a VVIR pacemaker.
Sample Size Accounting for attrition, an estimated enrollment of 1830 patients will be required to achieve the desired sample size for the primary objectives.
Data Collection To estimate acute complication rate related to the Micra system and/or procedure: 1741 Micra system implant procedure ensure complication detection and produces a 2-sided 95% CI width of 1.0% when the event rate is 1%



To estimate the 9-year Micra related complication free survival probability: 500 patients at 9-years produces a 2-sided CI width of 6.5% with a CI lower limit of 85.0%

Follow-up Visits and Length of Follow-up The study aims to follow at least 500 patients out to 9 years.

Annually



ODE Lead-Micra Rate Resp Conf Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 04/06/2017 04/06/2017 On Time
18 month report 10/05/2017 10/04/2017 On Time
two year report 04/06/2018    
Final Report 08/06/2018    


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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