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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Prometra Programmable Pump system

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Application Number P080012 / PAS001
Current Plan Approved 12/28/2015
Study Name OSB Lead-Prometra Programmable Pump system
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, non-randomized, open-label, multicenter study, which will include subjects from the premarket study cohorts and new enrollment of subjects receiving the device in the postmarket.
Study Population Description Group A: Active prospective study subjects.

Group B: Subjects previously enrolled in the premarket trials PUMP I or PUMP II will be offered voluntary participation in the post-approval study. Subjects in Group B will be followed for a total of five years, which includes all time enrolled in the previous PUMP study.

Sample Size 400 patients
Data Collection Primary endpoint is to assess long-term occurrence and safety as a result of granuloma formation.

Secondary endpoints are to assess the long-term device performance including:

-Pump failure, including time to occurrence, type, and number of occurrences

-Pump battery life

The additional endpoint will include:

-Device-related adverse events

-Device-related serious adverse events

-The effect of race and ethnicity on granuloma formation

-The effect of alternative drugs on granuloma formation

Follow-up Visits and Length of Follow-up 5 years

Subjects shall be seen at least once every 90 days (± 30 days) from the date of implantation (Group A) or enrollment (Group B) throughout the study

OSB Lead-Prometra Programmable Pump system Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/07/2012 07/24/2012 On Time
one year report 02/06/2013 02/06/2013 On Time
18 month report 08/07/2013 08/05/2013 On Time
two year report 02/06/2014 02/06/2014 On Time
three year report 02/06/2015 02/04/2015 On Time
four year report 02/06/2016 02/05/2016 On Time
five year report 02/05/2017    
six year report 02/05/2018    

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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