• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

PARCS continued f/u survey


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number P150028 S001/ PAS001
Date Current Protocol Accepted  
Study Name PARCS continued f/u survey
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this surveillance is to characterize longer-term safety and effectiveness of the CP Covered Stent when used for treatment of right ventricular outflow tract (RVOT) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement (TPVR).
Study Population Description Subject follow-up will be conducted via distribution of an annual survey to investigators who participated in the PARCS IDE and CAP. The investigational sites will be provided with the CASE ID numbers for all living subjects who were enrolled under the PARCS study or PARCS Continued Access Protocol (CAP) to assist with acquisition of follow up status. The survey distributed to the sites will request information on patients treated with a CP Covered Stent during transcatheter pulmonary valve implantation including: need for catheter or surgical reintervention for a new or enlarging RVOT aneurysm/pseudo-aneurysm, instances of progression of aneurysm or pseudo-aneurysm, instances of structural failure (fracture), or need for device explantation. Survey distribution will continue annually until all patients reach 10 years post-implant. The sponsor will acquire this information from PARCS investigators/hospitals and report results to FDA on an annual basis.
Sample Size Those patients in the PARCS IDE and CAP
Data Collection The survey distributed to the sites will request information on patients treated with a CP Covered Stent during transcatheter pulmonary valve implantation including: need for catheter or surgical reintervention for a new or enlarging RVOT aneurysm/pseudo-aneurysm, instances of progression of aneurysm or pseudo-aneurysm, instances of structural failure (fracture), or need for device explantation.
Follow-up Visits and Length of Follow-up 10 years


PARCS continued f/u survey Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 10/24/2018    
two year report 10/24/2019    
three year report 10/23/2020    
four year report 10/23/2021    


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

Related Links

-
-