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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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OmniaSecure PAS


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General
Study Status Study Pending
Application Number /
Requirement Number		 P240036 / PAS001
Date Original Protocol Accepted 04/22/2025
Date Current Protocol Accepted  
Study Name OmniaSecure PAS
Device Name OmniaSecure™ MRI SureScan™ Lead Model 3930M
Clinical Trial Number(s) NCT04863664 
General Study Protocol Parameters
Study Design Other Study Design
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The purpose of this study is to characterize the long-term safety and estimate the lead-related complication-free survival of the Model 3930M Lead using registry data (Product Surveillance Registry)
Study Population Adolescent pediatric (>12 years old) and adults.
Sample Size 2000 patients, including 125 adolescent patients, from approximately 250 US and OUS sites
Key Study Endpoints Primary Objective: Estimate Model 3930M Lead-related complication-free survival through five (5) years post implant. For an adverse event to meet the endpoint, defined as a first occurrence of a complication related to the Model 3930M Lead of an enrolled patient as determined by the CEC, the event must have occurred within five (5) years post-lead implant and be adjudicated by the CEC as being a complication related to the lead.
a. The following complications will be included in the analysis:
i. Failure to capture
ii. Failure to sense/undersensing
iii. Oversensing
iv. Elevated threshold
v. Abnormal pacing/defibrillation impedance
vi. Lead insulation breach
vii. Lead conductor fracture
viii. Extracardiac Stimulation
ix. Lead migration/dislodgement
x. Cardiac perforation
xi. Lead structural failure
xii. Erosion/extrusion
xiii. Infection
xiv. Transvenous lead-related thrombosis

Ancillary objectives will include the following:
1. Summarize patient demographics
2. Summarize Model 3930M Lead-related adverse events
3. Summarize patient deaths
4. Summarize all Model 3930M Lead system modifications
5. Summarize Model 3930M Lead electrical performance
Follow-up Visits and Length of Follow-up The study will complete when approximately 500 patients have completed 5 years of follow-up. The total estimated PAS duration is 7 years.


OmniaSecure PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/21/2025    
1 year report 04/22/2026    
18 month report 10/21/2026    
2 year report 04/22/2027    
3 year report 04/21/2028    
4 year report 04/21/2029    
5 year report 04/21/2030    
6 year report 04/21/2031    
7 year report 04/20/2032    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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