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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

 

 

 

 

            

ADVANCE ASO


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS130046 / PSS001
Date Current Plan Accepted 06/20/2014
Study Name ADVANCE ASO
Root Document Number P000039 
General Study Protocol Parameters
Study Design Case Control Study
Data Source Other Data Source
Comparison Group Historical Control
Analysis Type Analytical
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The manufacturer used data from a published study to fulfill the postmarket surveillance (522) order (McElhinney et al. Circulation.2016;133:1738-1746). The study was a matched case-control study conducted to evaluate relative risk factors for cardiac erosion after ASD closure with an Amplatzer Septal Occluder (cases).

Study Population Description Cases: all erosions events reported to St. Jude Medical after ASD closure with an Amplatzer Septal Occluder reported through 2014. These erosion events were identified through product surveillance complaints, the prospective post-approval study (PAS), and monitoring of the MAUDE database and the published literature.



Controls: Subjects were selected from the post-approval study (P000039/PAS1).



Sample Size 125 cases and 250 controls matched by age and gender

Data Collection Primary endpoint: Cardiac erosion.



Erosion events were identified through product surveillance complaints, the prospective post-approval study (PAS), and monitoring of the MAUDE database and the published literature. An Erosion Board determined whether the event is likely to be attributable to erosion and adjudicates on certain technical, anatomic, and other aspects of the case.



Data was collected retrospectively for erosion cases and prospectively for the controls in the PAS.

Follow-up Visits and Length of Follow-up n/a



ADVANCE ASO Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/19/2014 12/19/2014 On Time
1 yr report 06/20/2015 06/18/2015 On Time
18 month report 12/19/2015 12/16/2015 On Time
2 yr report 06/19/2016 07/07/2016 On Time
final report 11/10/2017 11/14/2017 On Time


  • 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
WO66-2252
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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