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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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PCM Cervical Enhanced Surveillance

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Study Status Progress Adequate
Application Number P100012 / PAS001
Date Current Protocol Accepted 08/25/2015
Study Name PCM Cervical Enhanced Surveillance
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

PCM Cervical Enhanced Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/26/2013 04/24/2013 On Time
one year report 10/26/2013 10/25/2013 On Time
18 month report 04/26/2014 04/24/2014 On Time
two year report 10/26/2014 10/21/2014 On Time
three year report 10/26/2015 10/23/2015 On Time
four year report 10/25/2016 10/26/2016 Overdue/Received
five year report 10/25/2017 10/25/2017 On Time
six year report 10/25/2018 12/07/2018 Overdue/Received
seven year report 10/25/2019    
eight year report 10/26/2020    
nine year report 10/25/2021    
final report 11/25/2022    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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