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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval 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).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 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 PAS 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 PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

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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General
Application Number P060038 S017
Current Protocol Accepted 07/15/2014
Study Name NEMO PAS
Study Status Study Pending
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a prospective, non-randomized, multicenter post-

approval study (PAS)



Primary effectiveness:

*To evaluate the hemodynamic performance   show the rest ...
Study Population Description Patients who were implanted with Mitroflow, Model DL,

implantation according to the Instructions for Use (IFU).



Historical   show the rest ...
Sample Size Assuming a 32% mortality and 20% attrition rate into account, the PAS will include a   show the rest ...
Data Collection Occurrence of early and late structural valve deterioration (SVD) and valve-related complications (early and late),   show the rest ...
Followup Visits and Length of Followup 8 years

¿Pre-implant

¿Implant

¿Post-operative (within 30 days of implant)

¿Annual clinical and echocardiographic follow-up

  show the rest ...


NEMO PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 10/17/2014    
one year report 04/18/2015    
18 month report 10/17/2015    
two year report 04/17/2016    
three year report 04/17/2017    
four year report 04/17/2018    
five year report 04/17/2019    

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