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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

SUI AE and Effectiveness rates


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General
522 Number / Requirement Number PS120089 / PSS001
Current Plan Approved 08/29/2014
Study Name SUI AE and Effectiveness rates
Root Document Number K073703  K100807  K071902  K121641 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a multi-center randomized controlled trial comparing efficacy and morbidity of MiniArc and transobturator Monarc.
Study Population Description The study population is women with symptomatic stress urinary incontinence treated with Monarc or MiniArc

Sample Size 172 subjects (86 patients treated with MiniArc Sling System and 86 patients treated with Monarc Subfascial Hammock as controls) were enrolled at 5 sites in the Netherlands, Belgium and France
Data Collection Primary Effectiveness Endpoints: 1. Subjective cure; 2. Pain. Secondary Endpoints: 1. Objective cure; 2. Device-related serious adverse events; 3. Morbidity; 4. Duration of catheter use; 5. Disease and domain specific quality of life; 6. Quality of life; 7. Performed interventions in the first year after SUI surgery.
Follow-up Visits and Length of Follow-up The length of study follow-up is 3 years. Follow-up will be conducted at 1 month, 6 months, 12 months, 18 months, 24 months and 36 months.


SUI AE and Effectiveness rates Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/01/2013 08/01/2013 On Time
1 yr report 01/31/2014 02/03/2014 Overdue/Received
18 month report 08/01/2014 08/04/2014 Overdue/Received
2 yr report 01/31/2015 02/02/2015 Overdue/Received
3 yr report 01/31/2016    
4 yr report 01/30/2017    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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